FDA Product Code
FDA Product Code JKA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1675
510(k) Clearances — 237 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K021698 | MY ALLERGY TEST | Immunetech Corporation | 2002-09-19 | Traditional | PDF ↗ |
| K022875 | MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET | Becton, Dickinson & CO | 2002-09-11 | Special | PDF ↗ |
| K022426 | BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538 | Becton, Dickinson & CO | 2002-08-08 | Special | PDF ↗ |
| K022130 | BD VACUTAINER PLUS PST II TUBE | Becton, Dickinson & CO | 2002-07-29 | Traditional | PDF ↗ |
| K021941 | SAMPLOK LUER KIT | Itl Corporation Pty, Ltd. | 2002-07-02 | Special | PDF ↗ |
| K012221 | SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM | Biosafe Laboratories, Inc. | 2002-04-03 | Traditional | PDF ↗ |
| K013971 | BD VACUTAINER SAFETY COAGULATION TUBE | Becton, Dickinson & CO | 2002-02-01 | Traditional | PDF ↗ |
| K011699 | VACUETTE EVACUATED BLOOD COLLECTION TUBES | Greiner Bio-One Vacuette North America | 2001-06-28 | Traditional | PDF ↗ |
| K002456 | MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 | Becton Dickinson Vacutainer Systems | 2000-11-02 | Traditional | PDF ↗ |
| K002777 | VACUETTE WITH PPACK | Greiner Vacuette North America, Inc. | 2000-10-05 | Traditional | PDF ↗ |
| K993787 | APPRAISE-CARDIO SAMPLE COLLECTION KIT | Osborn Group, Inc. | 2000-04-14 | Traditional | PDF ↗ |
| K000777 | SAMPLOK | Itl Corporation Pty, Ltd. | 2000-04-11 | Traditional | PDF ↗ |
| K991551 | VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1999-09-23 | Traditional | PDF ↗ |
| K991702 | MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 | Becton Dickinson Vacutainer Systems | 1999-07-28 | Traditional | PDF ↗ |
| K992244 | GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE | Greiner Meditech, Inc. | 1999-07-26 | Traditional | PDF ↗ |
| K991843 | GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE | Greiner Meditech, Inc. | 1999-06-25 | Traditional | PDF ↗ |
| K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE | Becton Dickinson Vacutainer Systems | 1999-05-28 | Traditional | PDF ↗ |
| K991120 | VACUTAINER BRAND CTAD TUBE (MULTIPLE) | Becton Dickinson Vacutainer Systems | 1999-05-19 | Traditional | PDF ↗ |
| K983952 | GREINER VACUETTE BLOOD COLLECTION TUBE | Greiner Meditech, Inc. | 1998-12-28 | Traditional | PDF ↗ |
| K983490 | TERUMO VENOJECT,LUER ADAPTER | Terumo Corp. | 1998-11-30 | Traditional | PDF ↗ |
| K983517 | SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM | Ram Scientific | 1998-11-12 | Traditional | PDF ↗ |
| K982998 | GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE | Greiner Meditech, Inc. | 1998-10-21 | Traditional | PDF ↗ |
| K982999 | GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE | Greiner Meditech, Inc. | 1998-10-16 | Traditional | PDF ↗ |
| K982922 | VACUTAINER BRAND BLOOD COLLECTION SYRINGE | Becton Dickinson Vacutainer Systems | 1998-09-22 | Traditional | PDF ↗ |
| K981973 | SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM | Ram Scientific | 1998-09-03 | Traditional | PDF ↗ |
| K981013 | VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE | Becton Dickinson Vacutainer Systems | 1998-06-17 | Traditional | PDF ↗ |
| K981035 | PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES | Sims Portex, Inc. | 1998-04-21 | Traditional | PDF ↗ |
| K980414 | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-03-03 | Traditional | PDF ↗ |
| K980098 | VACUTAINER BRAND PRONTO NEEDLES HOLDER | Becton Dickinson Vacutainer Systems | 1998-02-05 | Traditional | PDF ↗ |
| K974873 | VACUETTE (MULTI-USE HOLDER) | Greiner Meditech, Inc. | 1998-02-05 | Traditional | PDF ↗ |
| K974374 | SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV | Ohmeda Medical | 1998-01-02 | Traditional | PDF ↗ |
| K971111 | TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER | Tri-Tech, Inc. | 1997-06-16 | Traditional | PDF ↗ |
| K971220 | GREINER VACUETTE BLOOD COLLECTION TUBE | Greiner America, Inc. | 1997-06-04 | Traditional | PDF ↗ |
| K971236 | GREINER VACUETTE BLOOD COLLECTION TUBE | Greiner America, Inc. | 1997-05-12 | Traditional | PDF ↗ |
| K971239 | GREINER VACUETTE BLOOD COLLECTION TUBE | Greiner America, Inc. | 1997-05-12 | Traditional | PDF ↗ |
| K964698 | SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT | Andwin Scientific | 1997-03-03 | Traditional | PDF ↗ |
| K965202 | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997-02-10 | Traditional | PDF ↗ |
| K962158 | PICO MODELS 30, 50, 70 | Radiometer America, Inc. | 1996-10-29 | Traditional | PDF ↗ |
| K962931 | SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT | Smiths Industries Medical Systems, Inc. | 1996-10-21 | Traditional | PDF ↗ |
| K960860 | GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3 | Greiner America, Inc. | 1996-09-05 | Traditional | PDF ↗ |
| K960858 | GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR | Greiner America, Inc. | 1996-08-30 | Traditional | PDF ↗ |
| K960857 | GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR | Greiner America, Inc. | 1996-08-30 | Traditional | PDF ↗ |
| K960250 | VACUTAINER BRAND PLUS SERUM & SST TUBES | Becton Dickinson Vacutainer Systems | 1996-03-29 | Traditional | PDF ↗ |
| K936240 | SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE) | Sudormed, Inc. | 1996-03-19 | Traditional | PDF ↗ |
| K954592 | VACUTAINER BRAND PST PLASMA SEPARATION TUBE | Becton Dickinson Vacutainer Systems | 1995-11-28 | Traditional | PDF ↗ |
| K953994 | SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM | Becton Dickinson Vacutainer Systems | 1995-09-26 | Traditional | PDF ↗ |
| K953463 | VACUTAINER PLUS TUBES | Becton Dickinson Vacutainer Systems | 1995-09-20 | Traditional | PDF ↗ |
| K952516 | PRO-VENT, LINE DRAW, PULSATOR | Smiths Industries Medical Systems, Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K935588 | SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION | Sudormed, Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K935564 | SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION | Sudormed, Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K926253 | SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE | Sudormed, Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K944083 | MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE | Sherwood Medical Co. | 1995-05-26 | Traditional | PDF ↗ |
| K944618 | NEONATAL BLOOD COLLECTION AND SCREENING FORM | General Business Forms, Inc. | 1995-05-10 | Traditional | PDF ↗ |
| K950432 | VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-05-05 | Traditional | PDF ↗ |
| K945454 | LEUR TIP CAP, VLT CAP(TM) | Martell Medical Products, Inc. | 1995-04-14 | Traditional | PDF ↗ |
| K945245 | BLOOD KIT, SEXUAL ASSAULT KIT | Lynn Peavey Co. | 1995-02-01 | Traditional | PDF ↗ |
| K945952 | VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-01-18 | Traditional | PDF ↗ |
| K945777 | PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES | Smiths Industries Medical Systems, Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K945353 | CLARIT(TM) | Advanced Biomedical Methods, Inc. | 1994-12-09 | Traditional | PDF ↗ |
| K944566 | VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-11-10 | Traditional | PDF ↗ |
| K942241 | DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN | Dupont Medical Products | 1994-08-18 | Traditional | PDF ↗ |
| K942240 | DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN | Dupont Medical Products | 1994-08-17 | Traditional | PDF ↗ |
| K940905 | MICROTAINER BRAND TUBE WITH EDTA(K2) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-08-02 | Traditional | PDF ↗ |
| K941159 | DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G | International Technidyne Corp. | 1994-05-19 | Traditional | PDF ↗ |
| K922343 | TRI-TECH INC. CUSTOM SEXUAL ASSAULT KIT | Tri-Tech, Inc. | 1994-02-17 | Traditional | PDF ↗ |
| K933401 | THE BUCK | Medical Implements, Inc. | 1994-02-10 | Traditional | PDF ↗ |
| K935081 | DIRECTDRAW SUPERSERUM-MINI | International Technidyne Corp. | 1994-01-11 | Traditional | PDF ↗ |
| K931368 | MICROTAINER BRAND TUBE WITH EDTA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-09-28 | Traditional | PDF ↗ |
| K922342 | TRI-TECH INC. CUSTOM BLOOD ALCOHOL | Tri-Tech, Inc. | 1993-08-27 | Traditional | PDF ↗ |
| K931924 | MARKSMAN ARTERIAL BLOOD GAS SYRINGE | Martech Medical Products, Inc. | 1993-08-03 | Traditional | PDF ↗ |
| K931367 | VACUTAINER BRAND LUER ADAPTER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-05-11 | Traditional | PDF ↗ |
| K924364 | VACUPLUS TUBES WITH GREY STOPPERS | Starplex Scientific, Inc. | 1993-03-01 | Traditional | PDF ↗ |
| K924362 | VACUPLUS TUBES WITH LAVANDER STOPPERS | Starplex Scientific, Inc. | 1993-03-01 | Traditional | PDF ↗ |
| K924361 | VACUPLUS TUBES WITH GREEN STOPPERS | Starplex Scientific, Inc. | 1993-03-01 | Traditional | PDF ↗ |
| K924363 | VACUPLUS(R) STAR-SEP(TM) | Starplex Scientific, Inc. | 1993-02-08 | Traditional | PDF ↗ |
| K924365 | VACUPLUS TUBES WITH BRICK RED STOPPERS | Starplex Scientific, Inc. | 1992-12-28 | Traditional | PDF ↗ |
| K923090 | SAF-T HOLDER MULTI SAMPLE LUER ADAPTER W/ BLOOD | Ryan Medical, Inc. | 1992-09-01 | Traditional | PDF ↗ |
| K922445 | VACU-PRO | Concord/Portex | 1992-08-12 | Traditional | PDF ↗ |
| K921520 | VACUTAINER BRAND LUER ADAPTER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-07-10 | Traditional | PDF ↗ |
| K921806 | VACUTAINER(R) BRAND SST(R) AND CAT TUBES | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-04-29 | Traditional | PDF ↗ |
| K915814 | SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS | Sirchie Finger Print Laboratories, Inc. | 1992-03-27 | Traditional | PDF ↗ |
| K913399 | QBC E-Z PREP | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-10-18 | Traditional | PDF ↗ |
| K910970 | MARKSMAN ARTERIAL BLOOD GAS SYRINGE | Martech Medical Products, Inc. | 1991-10-15 | Traditional | PDF ↗ |
| K914129 | DIFF SAFE | Marshall Levinson | 1991-10-11 | Traditional | PDF ↗ |
| K911809 | NEW-VENT | Concord/Portex | 1991-08-26 | Traditional | PDF ↗ |
| K911638 | SYRINGE TIP CAP | Concord/Portex | 1991-06-21 | Traditional | PDF ↗ |
| K910646 | SUPERSERUM REAGENT (SSR) | International Technidyne Corp. | 1991-05-10 | Traditional | PDF ↗ |
| K902442 | SUDORMED SWEAT PATCH SPECIMEN CONTAINER | Sudormed, Inc. | 1990-10-04 | Traditional | PDF ↗ |
| K900856 | VEN-O-VAC BLOOD COLLECTION VACUUM TUBES | Artefactos DE Vidrio S.A. DE C.V. | 1990-09-21 | Traditional | PDF ↗ |
| K901756 | INTERJECTOR BLOOD COLLECTION DEVICE | Bowman/Vector, Inc. | 1990-08-29 | Traditional | PDF ↗ |
| K901449 | VACUTAINER PLUS WITH HEMOGARD CLOSURE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-08-09 | Traditional | PDF ↗ |
| K902709 | SECUTAINER | Preserve | 1990-07-27 | Traditional | PDF ↗ |
| K900726 | MICROTEK MEDICAL'S BLOOD COLLECTION KIT | Microbio-Medics, Inc. | 1990-05-04 | Traditional | PDF ↗ |
| K900309 | VENOJECT II BLOOD COLLECTION TUBES | Terumo Medical Corp. | 1990-03-15 | Traditional | PDF ↗ |
| K896206 | STATSPIN STATSAMPLER | Statspin Technologies | 1989-11-22 | Traditional | PDF ↗ |
| K892665 | PRO-JECT(TM) SAFETY NEEDLE HOLDER | Pro-Tec Containers, Inc. | 1989-10-04 | Traditional | PDF ↗ |
| K884970 | PINSET | Safety Diagnostics, Inc. | 1989-09-07 | Traditional | PDF ↗ |
| K893613 | STATSPIN MINI-PLASMA | Statspin Technologies | 1989-08-28 | Traditional | PDF ↗ |
| K890109 | SAFEPETTE DISPENSER | Safe-Tec Clinical Products, Inc. | 1989-02-23 | Traditional | PDF ↗ |
| K884807 | LIPOCLEAR LIPEMIA CLEARING REAGENT | Statspin Technologies | 1989-01-27 | Traditional | PDF ↗ |
Product code JKA · Class II · Clinical Chemistry. Data: openFDA.