FDA Product Code
FDA Product Code JJX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1660
510(k) Clearances — 493 records · page 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K970148 | ELECSYS CALCHECK ESTRADIOL | Boehringer Mannheim Corp. | 1997-02-10 | Traditional | PDF ↗ |
| K970176 | HCG CONTROLS | International Newtech Development, Inc. | 1997-02-06 | Traditional | PDF ↗ |
| K970146 | ELECSYS CALCHECK TESTOSTERONE | Boehringer Mannheim Corp. | 1997-01-30 | Traditional | PDF ↗ |
| K964830 | ELECSYS CALCHECK LH | Boehringer Mannheim Corp. | 1996-12-16 | Traditional | PDF ↗ |
| K964278 | WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 | Clinical Controls, Inc. | 1996-11-22 | Traditional | PDF ↗ |
| K963909 | HEMOCUE GLUCOLIN | Direct Solutions | 1996-11-08 | Traditional | PDF ↗ |
| K964053 | HEMOCUE GLUCOTROL | Direct Solutions | 1996-11-01 | Traditional | PDF ↗ |
| K961432 | RADIAS GALT TEST | Bio-Rad | 1996-10-28 | Traditional | PDF ↗ |
| K963551 | BIO-CSF LIQUID CONTROL LEVEL 1 AND 2 | Biocell Laboratories, Inc. | 1996-10-07 | Traditional | PDF ↗ |
| K963181 | ELECSYS CALCHECK T UPDATE | Boehringer Mannheim Corp. | 1996-09-10 | Traditional | PDF ↗ |
| K963165 | ELECSYS CALCHECK HCG | Boehringer Mannheim Corp. | 1996-08-30 | Traditional | PDF ↗ |
| K963240 | IMMULITE ACTH CONTROL MODULE (LACCM) | Diagnostic Products Corp. | 1996-08-29 | Traditional | PDF ↗ |
| K962975 | PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) | Diagnostic Products Corp. | 1996-08-29 | Traditional | PDF ↗ |
| K963164 | ELECSYS CALCHECK FT4 | Boehringer Mannheim Corp. | 1996-08-27 | Traditional | PDF ↗ |
| K963163 | ELECSYS CALCHECK FT3 | Boehringer Mannheim Corp. | 1996-08-27 | Traditional | PDF ↗ |
| K963178 | ELECSYS CALCHECK T4 | Boehringer Mannheim Corp. | 1996-08-27 | Traditional | PDF ↗ |
| K963167 | ELECYS CALCHECK T 3 | Boehringer Mannheim Corp. | 1996-08-27 | Traditional | PDF ↗ |
| K963147 | ELECSYS CALCHECK TSH | Boehringer Mannheim Corp. | 1996-08-23 | Traditional | PDF ↗ |
| K963182 | ELECSYS CALCHECK CK-MB | Boehringer Mannheim Corp. | 1996-08-23 | Traditional | PDF ↗ |
| K963143 | ELECSYS CALCHECK TROPONIN T | Boehringer Mannheim Corp. | 1996-08-23 | Traditional | PDF ↗ |
| K963085 | LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III | International Enzymes, Inc. | 1996-08-20 | Traditional | PDF ↗ |
| K962841 | OPUS MYOGLOBIN CONTROLS | Behring Diagnostics, Inc. | 1996-08-15 | Traditional | PDF ↗ |
| K962694 | OPUS B12 CONTROLS | Behring Diagnostics, Inc. | 1996-07-22 | Traditional | PDF ↗ |
| K962573 | ELECSYS PRECICONTROL TSH | Boehringer Mannheim Corp. | 1996-07-22 | Traditional | PDF ↗ |
| K962432 | LIQUISPEX URINE (MICRO)ALBUMIN CONTROL | Clinical Controls, Inc. | 1996-07-05 | Traditional | PDF ↗ |
| K961510 | ACS FRT4 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1996-06-17 | Traditional | PDF ↗ |
| K960874 | COMPLEMENT CONTROL | Wako Chemicals USA, Inc. | 1996-06-14 | Traditional | PDF ↗ |
| K961206 | OPUS T3 CONTROLS | Behring Diagnostics, Inc. | 1996-04-23 | Traditional | PDF ↗ |
| K960378 | ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS | Actimed Laboratories, Inc. | 1996-04-03 | Traditional | PDF ↗ |
| K955629 | LXN FRUCTOSAMINE TEST | Lxn Corp. | 1996-03-20 | Traditional | PDF ↗ |
| K960154 | PSA CONTROLS | Diagnostic Products Corp. | 1996-03-13 | Traditional | PDF ↗ |
| K955796 | IRON CALIBRATOR & CALIBRATION VERIFICATION SET | Data Medical Associates, Inc. | 1996-02-29 | Traditional | PDF ↗ |
| K955468 | OPUS PROLACTIN CONTROLS | Behring Diagnostics, Inc. | 1996-02-23 | Traditional | PDF ↗ |
| K955141 | OSOM HCG COMBO TEST | Wyntek Diagnostics, Inc. | 1995-12-06 | Traditional | PDF ↗ |
| K953883 | ACCESS LOW LEVEL IGE CONTROLS | Bio-Rad Laboratories, Inc. | 1995-11-14 | Traditional | PDF ↗ |
| K954144 | OPUS HCG CONTROLS | Behring Diagnostics, Inc. | 1995-10-06 | Traditional | PDF ↗ |
| K952251 | IMMULITE HCG HIGH LEVEL CONTROL MODULE | Diagnostic Products Corp. | 1995-09-08 | Traditional | PDF ↗ |
| K953097 | OPUS T4 CONTROLS | Behring Diagnostics, Inc. | 1995-08-24 | Traditional | PDF ↗ |
| K951888 | DADE STRATUS TROPONIN-I CONTROL | Dade Intl., Inc. | 1995-07-13 | Traditional | PDF ↗ |
| K944999 | SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 | More Diagnostics | 1995-06-06 | Traditional | PDF ↗ |
| K950072 | IMMULITE(R) TBG | Diagnostic Products Corp. | 1995-04-03 | Traditional | PDF ↗ |
| K950590 | REP CHOLESTEROL PROFILE CONTROL | Helena Laboratories | 1995-03-30 | Traditional | PDF ↗ |
| K950589 | CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL | Creative Laboratory Products, Inc. | 1995-03-20 | Traditional | PDF ↗ |
| K946144 | LIQUISPEX(TM) URINE ETHANOL CONTROL | Clinical Controls, Inc. | 1995-02-08 | Traditional | PDF ↗ |
| K946143 | CHEMSPEX(TM) AMMONIA CONTROL | Clinical Controls, Inc. | 1995-02-03 | Traditional | PDF ↗ |
| K944785 | SAS QUANT HCG SERUM | Sa Scientific, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K945718 | DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET | Casco Standards | 1995-01-17 | Traditional | PDF ↗ |
| K944361 | DOCUMENT R AMMONIA/ETHANOL CONTROL | Casco Standards | 1994-11-30 | Traditional | PDF ↗ |
| K944453 | QUANTITATE URIC ACID VERIFIER SET | Beckman Instruments, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K944515 | SERUM PROTEIN CONTROLS | Pyramid Biological Corp. | 1994-11-17 | Traditional | PDF ↗ |
| K944891 | SAS QUANT HCG URINE | Sa Scientific, Inc. | 1994-11-17 | Traditional | PDF ↗ |
| K944338 | DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET | Casco Standards | 1994-11-15 | Traditional | PDF ↗ |
| K942632 | TNT TROPONIN T | Streck Laboratories, Inc. | 1994-09-09 | Traditional | PDF ↗ |
| K942284 | CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET | Creative Laboratory Products, Inc. | 1994-08-26 | Traditional | PDF ↗ |
| K941433 | HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH | Hichem Diagnostics | 1994-08-02 | Traditional | PDF ↗ |
| K935611 | AXSYM LUTEINIZING HORMONE (LH) | Abbott Laboratories | 1994-06-21 | Traditional | PDF ↗ |
| K940577 | GLUCOMETER ELITE LOW CONTROL | Heraeus Kulzer, Inc. | 1994-06-13 | Traditional | PDF ↗ |
| K941130 | ASSURE URINE HCG CONTROL | Quantimetrix Corp. | 1994-06-03 | Traditional | PDF ↗ |
| K940142 | GLYCATED PROTEIN CONTROLS | Primus Corp. | 1994-04-26 | Traditional | PDF ↗ |
| K940272 | ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL | Analytical Control Systems, Inc. | 1994-04-20 | Traditional | PDF ↗ |
| K940568 | DOCUMENT(R) ZERO | Casco Standards | 1994-04-05 | Traditional | PDF ↗ |
| K935606 | SERUM AMMONIA CONTROL | P.T. Meditrol | 1994-03-22 | Traditional | PDF ↗ |
| K933218 | REFRACTOMETRIC, TOTAL PROTEIN | Pyramid Biological Corp. | 1994-02-17 | Traditional | PDF ↗ |
| K935362 | P-AMYLASE CONTROL | Beckman | 1994-01-27 | Traditional | PDF ↗ |
| K934922 | CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET | Unipath , Ltd. | 1993-12-29 | Traditional | PDF ↗ |
| K934923 | CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET | Unipath , Ltd. | 1993-12-29 | Traditional | PDF ↗ |
| K932479 | B-HCG HUMAN SERUM CONTROLS | Pyramid Biological Corp. | 1993-12-02 | Traditional | PDF ↗ |
| K934521 | SPQ MALB CONTROL LEVEL II | Incstar Corp. | 1993-11-26 | Traditional | PDF ↗ |
| K932660 | LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2 | More Diagnostics | 1993-10-28 | Traditional | PDF ↗ |
| K933744 | SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES | Sa Scientific, Inc. | 1993-09-24 | Traditional | PDF ↗ |
| K932178 | AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES | Tosoh Medics, Inc. | 1993-09-21 | Traditional | PDF ↗ |
| K930007 | IMMULITE TSH THIRD GENERATION CONTROL | Diagnostic Products Corp. | 1993-08-16 | Traditional | PDF ↗ |
| K932870 | DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET | Casco Standards | 1993-08-02 | Traditional | PDF ↗ |
| K932658 | CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3 | More Diagnostics | 1993-07-28 | Traditional | PDF ↗ |
| K932659 | MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM | More Diagnostics | 1993-07-28 | Traditional | PDF ↗ |
| K932113 | CANNABINOID URINE CONTROLS | Diagnostic Reagents, Inc. | 1993-06-29 | Traditional | PDF ↗ |
| K931761 | QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI) | Quidel Corp. | 1993-06-22 | Traditional | PDF ↗ |
| K924859 | AIA-PACK IGE CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | 1993-05-14 | Traditional | PDF ↗ |
| K930874 | LD-1 CONTROL-LEVEL 1 & 2 | Cala Diagnostics | 1993-04-22 | Traditional | PDF ↗ |
| K925783 | AUTOSTAT ANTI-DSDNA | Cogent Diagnotics , Ltd. | 1993-03-22 | Traditional | PDF ↗ |
| K924860 | AIA-PACK AFP CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | 1993-03-04 | Traditional | PDF ↗ |
| K925906 | NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL | Analytical Control Systems, Inc. | 1993-02-18 | Traditional | PDF ↗ |
| K922754 | TANDEM-E IGE II CALIBRATION VERIFICATION SET | Hybritech, Inc. | 1993-02-17 | Traditional | PDF ↗ |
| K925880 | KODAK AMERLITE CK-MB CONTROL SERA LAN.4413 | Eastman Kodak Company | 1993-02-05 | Traditional | PDF ↗ |
| K925479 | SUGAR CHEX LINEARITY FOR THE ONE TOUCH | Streck Laboratories, Inc. | 1993-01-28 | Traditional | PDF ↗ |
| K926095 | REFRACTROL-SP | Medical Specialties, Inc. | 1993-01-26 | Traditional | PDF ↗ |
| K924852 | ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | 1993-01-11 | Traditional | PDF ↗ |
| K924493 | DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD | Casco Standards | 1993-01-11 | Traditional | PDF ↗ |
| K924856 | AIA-PACK PRL CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | 1993-01-11 | Traditional | PDF ↗ |
| K924853 | AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | 1992-12-28 | Traditional | PDF ↗ |
| K926015 | CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 | Cala Diagnostics | 1992-12-28 | Traditional | PDF ↗ |
| K924862 | AIA-PACK HCG CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | 1992-12-28 | Traditional | PDF ↗ |
| K924675 | TSH - THIRD GENERATION LOW CONTROLS | Nichols Institute | 1992-11-18 | Traditional | PDF ↗ |
| K924855 | AIA-PACK T-U CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | 1992-11-16 | Traditional | PDF ↗ |
| K924863 | AIA-PACK FSH CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | 1992-11-16 | Traditional | PDF ↗ |
| K924854 | AIA-PACK PAP CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | 1992-11-16 | Traditional | PDF ↗ |
| K923793 | DOCUMENT CHEM III CALIBRATION VERIFICATION TEST | Casco Standards | 1992-11-05 | Traditional | PDF ↗ |
| K923794 | DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET | Casco Standards | 1992-11-05 | Traditional | PDF ↗ |
| K923821 | DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET | Casco Standards | 1992-11-05 | Traditional | PDF ↗ |
| K922995 | LIPID CONTROLS | Creative Laboratory Products, Inc. | 1992-08-12 | Traditional | PDF ↗ |
Product code JJX · Class I · Clinical Chemistry. Data: openFDA.