FDA Product Code
FDA Product Code JJY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1660
510(k) Clearances — 673 records · page 5 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K931373 | ANALYZER: STAT PROFILE PLUS 10 ANALYZER | Nova Biomedical Corp. | 1993-06-15 | Traditional | PDF ↗ |
| K931139 | DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET | Casco Standards | 1993-05-12 | Traditional | PDF ↗ |
| K925326 | ELECTROPHORESIS CONTROL LEVEL 1 | Seradyn, Inc. | 1993-03-26 | Traditional | PDF ↗ |
| K924802 | CALIBRATION VERIFICATION KIT OR CVK | Radiometer America, Inc. | 1993-03-09 | Traditional | PDF ↗ |
| K925256 | QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL | Quantimetrix Corp. | 1993-03-01 | Traditional | PDF ↗ |
| K924061 | CANCER ANTIGEN CONTROL | Polymedco, Inc. | 1993-02-23 | Traditional | PDF ↗ |
| K926046 | DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III | Baxter Diagnostics, Inc. | 1993-01-05 | Traditional | PDF ↗ |
| K924915 | SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479 | Helena Laboratories | 1992-12-18 | Traditional | PDF ↗ |
| K923795 | DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET | Casco Standards | 1992-11-05 | Traditional | PDF ↗ |
| K921477 | I-STAT(TM) LEVELS 1,2,3 CONTROLS | I-Stat Corp. | 1992-11-02 | Traditional | PDF ↗ |
| K923632 | MULTIQUAL UNASSAYED PRODUCTS | Ciba Corning Diagnostics Corp. | 1992-10-13 | Traditional | PDF ↗ |
| K923633 | MULTIQUAL ASSAY PRODUCTS | Ciba Corning Diagnostics Corp. | 1992-10-13 | Traditional | PDF ↗ |
| K923740 | KODAK AMERLITE TOTAL THYROID CONTROL SERA | Eastman Kodak Company | 1992-09-25 | Traditional | PDF ↗ |
| K920291 | MONI-TROL-L AND MONI-TROL-XL | Medical Analysis Systems, Inc. | 1992-09-02 | Traditional | PDF ↗ |
| K923165 | AMERLITE FREE THYROID CONTROL SERA LAN.4002 | Eastman Kodak Company | 1992-08-10 | Traditional | PDF ↗ |
| K922046 | LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 | Bio-Rad | 1992-07-10 | Traditional | PDF ↗ |
| K920636 | DADE URINE CHEMISTRY CONTROL LEVELS I AND II | Baxter Diagnostics, Inc. | 1992-07-07 | Traditional | PDF ↗ |
| K920927 | KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024 | Helena Laboratories | 1992-06-19 | Traditional | PDF ↗ |
| K921286 | LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2 | Bio-Rad | 1992-06-09 | Traditional | PDF ↗ |
| K920926 | KEMTROL SERUM CONTROL-ABNORMAL | Helena Laboratories | 1992-05-07 | Traditional | PDF ↗ |
| K920940 | AMERLITE FREE THYROID CONTROL SERA LAN.4002 | Eastman Kodak Company | 1992-04-17 | Traditional | PDF ↗ |
| K920826 | HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL | Eastman Kodak Company | 1992-04-07 | Traditional | PDF ↗ |
| K920350 | CHEM-CHEM MULTI-ANALYTE (MODIFIED) | Streck Laboratories, Inc. | 1992-03-23 | Traditional | PDF ↗ |
| K914958 | RIATRAC PLUS | Becton Dickinson Advanced Diagnostics | 1992-03-18 | Traditional | PDF ↗ |
| K914204 | TRI-POINT LIQUIMMUNE LIGAND CONTROL LEVELS 1,2,3 | Medical Analysis Systems, Inc. | 1992-03-17 | Traditional | PDF ↗ |
| K914890 | N/T PROTEIN CONTROL UY | Behring Diagnostics, Inc. | 1992-02-06 | Traditional | PDF ↗ |
| K914255 | LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2 | Bio-Rad | 1992-01-09 | Traditional | PDF ↗ |
| K915191 | RAI-TROL ELEVATED LIPIDS CONTROL | Reagents Applications, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K914619 | CVM | Ciba Corning Diagnostics Corp. | 1991-11-22 | Traditional | PDF ↗ |
| K913133 | CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) | Bionostics, Inc. | 1991-09-27 | Traditional | PDF ↗ |
| K913224 | LIPID LINEARITY CONTROLS | Creative Laboratory Products, Inc. | 1991-09-25 | Traditional | PDF ↗ |
| K913687 | CHEM-CHEX | Streck Laboratories, Inc. | 1991-09-19 | Traditional | PDF ↗ |
| K912718 | ENZYME LINEARITY CONTROL | Phoenix Diagnostics, Inc. | 1991-09-06 | Traditional | PDF ↗ |
| K912455 | DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL | Baxter Healthcare Corp | 1991-08-12 | Traditional | PDF ↗ |
| K912725 | TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL | Creative Laboratory Products, Inc. | 1991-07-30 | Traditional | PDF ↗ |
| K912441 | LINEARITY TEST KITS | Boehringer Mannheim Corp. | 1991-07-17 | Traditional | PDF ↗ |
| K911984 | ANEMIA I, II | Ciba Corning Diagnostics Corp. | 1991-06-13 | Traditional | PDF ↗ |
| K911854 | DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL | Baxter Healthcare Corp | 1991-06-10 | Traditional | PDF ↗ |
| K911755 | CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE | Bionostics, Inc. | 1991-05-22 | Traditional | PDF ↗ |
| K911803 | HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED | Hichem Diagnostics | 1991-05-15 | Traditional | PDF ↗ |
| K910440 | DOCUMENT REFLECTANCE II LINEARITY TEST SET | Casco Standards | 1991-05-10 | Traditional | PDF ↗ |
| K911169 | ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I | Analytical Control Systems, Inc. | 1991-05-01 | Traditional | PDF ↗ |
| K911171 | ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III | Analytical Control Systems, Inc. | 1991-05-01 | Traditional | PDF ↗ |
| K904989 | CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II | Creative Laboratory Products, Inc. | 1991-01-23 | Traditional | PDF ↗ |
| K905389 | CHEM-CHEX LIPID | Streck Laboratories, Inc. | 1990-12-26 | Traditional | PDF ↗ |
| K904784 | CHOLESTECH L.D.X. LEVEL 1 CONTROL | Cholestech Corp. | 1990-12-18 | Traditional | PDF ↗ |
| K904781 | CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL | Cholestrech Corp. | 1990-12-18 | Traditional | PDF ↗ |
| K902740 | LDL-DIRECT CONTROLS | Isolab, Inc. | 1990-12-07 | Traditional | PDF ↗ |
| K904872 | HDL CHOLESTEROL CONTROL | Analytical Control Systems, Inc. | 1990-12-07 | Traditional | PDF ↗ |
| K904075 | CLINICAL CHEMISTRY CONTROL | Phoenix Diagnostics, Inc. | 1990-12-06 | Traditional | PDF ↗ |
| K904829 | ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL | Analytical Control Systems, Inc. | 1990-12-06 | Traditional | PDF ↗ |
| K904968 | QCLYTE PROTEIN BASED ISE CONTROL | Baxter Healthcare Corp | 1990-12-06 | Traditional | PDF ↗ |
| K904768 | KODATROL I AND II CONTROL AND DILUENT SET | Eastman Kodak Company | 1990-11-09 | Traditional | PDF ↗ |
| K904141 | TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III | Medical Analysis Systems, Inc. | 1990-11-01 | Traditional | PDF ↗ |
| K904099 | URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS | Hichem Diagnostics | 1990-10-26 | Traditional | PDF ↗ |
| K904293 | HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237) | Hichem Diagnostics | 1990-10-12 | Traditional | PDF ↗ |
| K903933 | DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2 | Baxter Healthcare Corp | 1990-10-04 | Traditional | PDF ↗ |
| K903566 | DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III | Baxter Healthcare Corp | 1990-09-24 | Traditional | PDF ↗ |
| K903310 | CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR | Medical Analysis Systems, Inc. | 1990-09-07 | Traditional | PDF ↗ |
| K903407 | AFFINITY HLH TEST SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-09-07 | Traditional | PDF ↗ |
| K903338 | KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL | Kenlor Industries, Inc. | 1990-09-07 | Traditional | PDF ↗ |
| K902909 | CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROL | Creative Laboratory Products, Inc. | 1990-08-22 | Traditional | PDF ↗ |
| K903190 | MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY | Medical Analysis Systems, Inc. | 1990-08-17 | Traditional | PDF ↗ |
| K903225 | CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT | Medical Analysis Systems, Inc. | 1990-08-17 | Traditional | PDF ↗ |
| K902616 | BILIRUBIN CONTROL | Phoenix Diagnostics, Inc. | 1990-07-19 | Traditional | PDF ↗ |
| K902094 | BLOOD GAS/ISE CONTROLS | Phoenix Diagnostics, Inc. | 1990-07-19 | Traditional | PDF ↗ |
| K902673 | HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND | Hi Chem, Inc. | 1990-07-17 | Traditional | PDF ↗ |
| K902235 | LVM QUALITY CONTROL SERUM | Ciba Corning Diagnostics Corp. | 1990-07-17 | Traditional | PDF ↗ |
| K902573 | PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM | Boehringer Mannheim Corp. | 1990-07-10 | Traditional | PDF ↗ |
| K902536 | PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM | Boehringer Mannheim Corp. | 1990-07-10 | Traditional | PDF ↗ |
| K902095 | BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS | Phoenix Diagnostics, Inc. | 1990-06-12 | Traditional | PDF ↗ |
| K901988 | DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET | Casco Standards | 1990-05-31 | Traditional | PDF ↗ |
| K901212 | LIG/TDM A, B, C | Ciba Corning Diagnostics Corp. | 1990-05-01 | Traditional | PDF ↗ |
| K900717 | TECHNICON TESTPOINT(TM) LIGAND CONTROL | Technicon Instruments Corp. | 1990-04-26 | Traditional | PDF ↗ |
| K901115 | MULTICONSTITUENT SERUM RANGE LINEARITY #88234 | Hichem Diagnostics | 1990-04-19 | Traditional | PDF ↗ |
| K900993 | CHEM-CHEX | Streck Laboratories, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K892642 | DADE(R) TDM CONTROL | Baxter Healthcare Corp | 1990-02-02 | Traditional | PDF ↗ |
| K895862 | CLP NORMAL LIPID CONTROL | Creative Laboratory Products, Inc. | 1990-01-19 | Traditional | PDF ↗ |
| K895905 | LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3 | Bio-Rad | 1990-01-18 | Traditional | PDF ↗ |
| K896246 | CLP COMPREHENSIVE LIPID CONTROL-LR | Creative Laboratory Products, Inc. | 1990-01-10 | Traditional | PDF ↗ |
| K896247 | CLP COMPREHENSIVE LIPID CONTROL-HR | Creative Laboratory Products, Inc. | 1990-01-10 | Traditional | PDF ↗ |
| K896522 | DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY | Casco Standards | 1990-01-02 | Traditional | PDF ↗ |
| K895943 | NORMAL AND ABNORMAL CONTROL SERA | Sclavo, Inc. | 1989-12-27 | Traditional | PDF ↗ |
| K894852 | SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS | Instrumentation Laboratory CO | 1989-09-28 | Traditional | PDF ↗ |
| K894078 | LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II | Bio-Rad | 1989-08-11 | Traditional | PDF ↗ |
| K894252 | LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM | Bio-Rad | 1989-08-01 | Traditional | PDF ↗ |
| K893580 | DADE LIPID-TROL | Baxter Healthcare Corp | 1989-07-20 | Traditional | PDF ↗ |
| K893141 | DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET | Casco Standards | 1989-06-23 | Traditional | PDF ↗ |
| K893142 | DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET | Casco Standards | 1989-06-23 | Traditional | PDF ↗ |
| K891680 | LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II | Bio-Rad | 1989-06-13 | Traditional | PDF ↗ |
| K891929 | MONI-TROL(R) | Baxter Healthcare Corp | 1989-05-09 | Traditional | PDF ↗ |
| K890708 | AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE) | Amersham Corp. | 1989-03-20 | Traditional | PDF ↗ |
| K890414 | RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109) | Amersham Corp. | 1989-03-15 | Traditional | PDF ↗ |
| K890470 | RIATRAC PLUS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-03-15 | Traditional | PDF ↗ |
| K890576 | KENLOR HUMAN SPINAL FLUID CONTROL LIQUID | Kenlor Industries, Inc. | 1989-03-09 | Traditional | PDF ↗ |
| K890442 | SHAPE-ACTIO URINALYSIS CONTROLS | Actio, Inc. | 1989-03-08 | Traditional | PDF ↗ |
| K884977 | GAS TRAK PLUS | United Diagnostics, Inc. | 1989-01-27 | Traditional | PDF ↗ |
| K883942 | HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL | Icl Scientific | 1988-11-10 | Traditional | PDF ↗ |
| K882486 | LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II | Bio-Rad | 1988-10-25 | Traditional | PDF ↗ |
| K883861 | DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST | Casco Standards | 1988-10-13 | Traditional | PDF ↗ |
Product code JJY · Class I · Clinical Chemistry. Data: openFDA.