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 4 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K971657 | ACCURUN 121 HAV IGM POSITIVE CONTROL | Boston Biomedica, Inc. | 1997-08-12 | Traditional | PDF ↗ |
| K972048 | ACCURUN 117 HBEAG POSITIVE CONTROL | Boston Biomedica, Inc. | 1997-08-12 | Traditional | PDF ↗ |
| K972235 | PRECICONTROL TUMOR MARKER 1 AND 2 | Boehringer Mannheim Corp. | 1997-08-12 | Traditional | PDF ↗ |
| K971406 | ACCURUN 120 HAV IGG POSITIVE CONTROL | Boston Biomedica, Inc. | 1997-08-07 | Traditional | PDF ↗ |
| K972307 | ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL | Boston Biomedica, Inc. | 1997-08-07 | Traditional | PDF ↗ |
| K972608 | RANDOX ASSAYED SPECIFIC PROTEIN CONTROL | Randox Laboratories, Ltd. | 1997-08-04 | Traditional | PDF ↗ |
| K972070 | NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS | Nichols Institute Diagnostics | 1997-06-26 | Traditional | PDF ↗ |
| K972214 | ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN) | Roche Diagnostic Systems, Inc. | 1997-06-24 | Traditional | PDF ↗ |
| K972080 | QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 | Consolidated Technologies, Inc. | 1997-06-18 | Traditional | PDF ↗ |
| K971952 | LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) | Bio-Rad | 1997-06-16 | Traditional | PDF ↗ |
| K971405 | SPECIALITY URINE 1,2 | Chiron Diagnostics Corp. | 1997-06-16 | Traditional | PDF ↗ |
| K971954 | LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398) | Bio-Rad | 1997-06-11 | Traditional | PDF ↗ |
| K971071 | LIQUID LIGAND 1,2,3 | Chiron Diagnostics Corp. | 1997-04-23 | Traditional | PDF ↗ |
| K970862 | SPINALSCOPICS | Quantimetrix Corp. | 1997-04-08 | Traditional | PDF ↗ |
| K970956 | CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5 | Chiron Diagnostics Corp. | 1997-04-08 | Traditional | PDF ↗ |
| K970979 | LIQUID CSF(LCR)1, LIQUID CSF(LCR)2 | Chiron Diagnostics Corp. | 1997-04-02 | Traditional | PDF ↗ |
| K970976 | CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 | Medical Analysis Systems, Inc. | 1997-04-02 | Traditional | PDF ↗ |
| K965114 | TUMOR MARKER CONTROL | Diagnostic Products Corp. | 1997-02-20 | Traditional | PDF ↗ |
| K970147 | ELECSYS CALCHECK PROLACTIN | Boehringer Mannheim Corp. | 1997-02-10 | Traditional | PDF ↗ |
| K965048 | VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-01-27 | Traditional | PDF ↗ |
| K965171 | LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426) | Bio-Rad | 1997-01-13 | Traditional | PDF ↗ |
| K964640 | CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92 | Canyon Diagnostics, Inc. | 1996-12-13 | Traditional | PDF ↗ |
| K963770 | BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS | Biocircuits Corp. | 1996-12-05 | Traditional | PDF ↗ |
| K964065 | N/T PROTEIN CONTROL SL | Behring Diagnostics, Inc. | 1996-11-06 | Traditional | PDF ↗ |
| K961941 | LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363 | Bio-Rad | 1996-09-16 | Traditional | PDF ↗ |
| K961359 | LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2 | Bioprocessing, Inc. | 1996-09-13 | Traditional | PDF ↗ |
| K963346 | STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3 | Consolidated Technologies, Inc. | 1996-09-09 | Traditional | PDF ↗ |
| K962982 | NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT | Nova Biomedical Corp. | 1996-08-23 | Traditional | PDF ↗ |
| K962997 | NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3 | Nova Biomedical Corp. | 1996-08-15 | Traditional | PDF ↗ |
| K961912 | QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET | Consolidated Technologies, Inc. | 1996-08-15 | Traditional | PDF ↗ |
| K961750 | DOCUMENT CARDIAC ASSAYED CONTROL | Casco Standards | 1996-07-22 | Traditional | PDF ↗ |
| K962630 | DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL | Casco Standards | 1996-07-22 | Traditional | PDF ↗ |
| K962575 | ELECSYS PRECICONTROL CARDIAC | Boehringer Mannheim Corp. | 1996-07-22 | Traditional | PDF ↗ |
| K961195 | CHEM-CHEX STAT | Streck Laboratories, Inc. | 1996-05-15 | Traditional | PDF ↗ |
| K961293 | QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2 | Consolidated Technologies, Inc. | 1996-05-02 | Traditional | PDF ↗ |
| K955691 | SERUM VOLATILES CONTROL LEVEL 1 & 2 | Clinical Controls, Inc. | 1996-04-24 | Traditional | PDF ↗ |
| K955690 | AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 | Clinical Controls, Inc. | 1996-04-24 | Traditional | PDF ↗ |
| K960824 | IMMUNOLOGY CONTROL | Medical Analysis Systems, Inc. | 1996-04-23 | Traditional | PDF ↗ |
| K960862 | LIPID CONTROL | Medical Analysis Systems, Inc. | 1996-04-03 | Traditional | PDF ↗ |
| K955812 | SYSCON TURMOR MARKER CONTROL | Scantibodies Laboratory, Inc. | 1996-03-12 | Traditional | PDF ↗ |
| K955858 | N/T PROTEIN CONTROL SY/L, M AND H | Behring Diagnostics, Inc. | 1996-02-21 | Traditional | PDF ↗ |
| K954247 | SYSCON CONTROL ASSAYED & UNASSAYED | Scantibodies Laboratory, Inc. | 1996-02-14 | Traditional | PDF ↗ |
| K955264 | NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2 | Nova Biomedical Corp. | 1996-02-02 | Traditional | PDF ↗ |
| K955252 | NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4 | Nova Biomedical Corp. | 1996-02-02 | Traditional | PDF ↗ |
| K955260 | NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION | Nova Biomedical Corp. | 1996-02-02 | Traditional | PDF ↗ |
| K954655 | ROCHE CONTROL SERUM N | Roche Diagnostic Systems, Inc. | 1995-12-21 | Traditional | PDF ↗ |
| K954656 | ROCHE CONTROL SERUM P | Roche Diagnostic Systems, Inc. | 1995-12-21 | Traditional | PDF ↗ |
| K955024 | LIQUICHEK ETHANOL/AMMONIA CONTROL | Bio-Rad | 1995-11-28 | Traditional | PDF ↗ |
| K954323 | MAS LIQUID URINALYSIS CONTROL | Medical Analysis Systems, Inc. | 1995-11-09 | Traditional | PDF ↗ |
| K954298 | VIROTROL IV | Blackhawk Biosystems, Inc. | 1995-11-01 | Traditional | PDF ↗ |
| K954074 | AALTO SCIENTIFIC LIQUID CARDIAC CONTROL | Aalto Scientific, Ltd. | 1995-10-07 | Traditional | PDF ↗ |
| K952385 | HEMA-TROL Q-CHECK | Medical Specialties Intl., Inc. | 1995-09-25 | Traditional | PDF ↗ |
| K952877 | CSF LIQUID CEREBROSPINAL FLUID CONTROL | Medical Analysis Systems, Inc. | 1995-08-24 | Traditional | PDF ↗ |
| K942647 | COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI | Scantibodies Laboratory, Inc. | 1995-07-12 | Traditional | PDF ↗ |
| K950802 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM | International Enzymes, Inc. | 1995-06-01 | Traditional | PDF ↗ |
| K943394 | PROSTAT CONTROL | Quantimetrix Corp. | 1995-05-23 | Traditional | PDF ↗ |
| K945651 | LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3 | Bio-Rad | 1995-05-16 | Traditional | PDF ↗ |
| K951749 | BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 | Biocell Laboratories, Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K951170 | VIGIL MULTICHEK CONTROLS | Beckman Instruments, Inc. | 1995-04-20 | Traditional | PDF ↗ |
| K950469 | DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET | Casco Standards | 1995-04-11 | Traditional | PDF ↗ |
| K944728 | BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN ELECTROPHORESIS CONTROL | Bioresource Technology, Inc. | 1995-03-23 | Traditional | PDF ↗ |
| K944525 | LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3 | Medical Analysis Systems, Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K950326 | KENLOR HUMAN SPINAL FLUID CONTROL | Kenlor Industries, Inc. | 1995-03-20 | Traditional | PDF ↗ |
| K942458 | PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED | Randox Laboratories, Ltd. | 1995-03-13 | Traditional | PDF ↗ |
| K950399 | RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL | Bionostics, Inc. | 1995-02-22 | Traditional | PDF ↗ |
| K946049 | LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2 | Clinical Controls, Inc. | 1995-02-10 | Traditional | PDF ↗ |
| K944455 | QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE) | Beckman Instruments, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K944454 | QUANITITATE GBCC VERIFIER SET | Beckman Instruments, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K943729 | DYE CHECK STRIPS 545-630 | Awareness Technology, Inc. | 1994-12-29 | Traditional | PDF ↗ |
| K945315 | DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL | Casco Standards | 1994-12-09 | Traditional | PDF ↗ |
| K944513 | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E | International Enzymes, Inc. | 1994-12-02 | Traditional | PDF ↗ |
| K944452 | QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE) | Beckman Instruments, Inc. | 1994-12-02 | Traditional | PDF ↗ |
| K944486 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E | International Enzymes, Inc. | 1994-12-02 | Traditional | PDF ↗ |
| K944059 | PROCHEQ 1 & 2 | Prisma Systems | 1994-11-15 | Traditional | PDF ↗ |
| K935599 | HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3 | Clinical Controls, Inc. | 1994-10-31 | Traditional | PDF ↗ |
| K942295 | VIROTROL TORCH | Blackhawk Biosystems, Inc. | 1994-10-07 | Traditional | PDF ↗ |
| K936245 | MULTI ANALYTE LINEARITY SET | Teco Diagnostics | 1994-10-04 | Traditional | PDF ↗ |
| K943290 | BILIRUBIN PLUS/PEDIATRIC CONTROLS | Medi-Tech, Inc. | 1994-09-14 | Traditional | PDF ↗ |
| K943754 | BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT | Bionostics, Inc. | 1994-09-14 | Traditional | PDF ↗ |
| K941328 | TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2 | Medical Analysis Systems, Inc. | 1994-08-18 | Traditional | PDF ↗ |
| K941698 | SERUM VOLATILES CONTROL - LEVELS 1 AND 2 | More Diagnostics | 1994-07-28 | Traditional | PDF ↗ |
| K941876 | WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2 | More Diagnostics | 1994-07-28 | Traditional | PDF ↗ |
| K941115 | ACS CARDIO-TROL CONTROL | Analytical Control Systems, Inc. | 1994-07-20 | Traditional | PDF ↗ |
| K941912 | N/T PROTEIN CONTROL SY/L, M, AND H | Behring Diagnostics, Inc. | 1994-06-16 | Traditional | PDF ↗ |
| K936184 | VIGIL PRX CHEMISTRY CONTROL | Beckman-Diagnostic Systems Group | 1994-04-15 | Traditional | PDF ↗ |
| K930534 | TMC I, II | Ciba Corning Diagnostics Corp. | 1994-04-04 | Traditional | PDF ↗ |
| K935219 | FERTILITY PLUS 1, 2, 3 | Ciba Corning Diagnostics Corp. | 1994-03-22 | Traditional | PDF ↗ |
| K940397 | ACS O DILVENT PROTEIN DILUTION MATRIX | Analytical Control Systems, Inc. | 1994-03-11 | Traditional | PDF ↗ |
| K933844 | PARA 4 PLUS | Streck Laboratories, Inc. | 1993-12-27 | Traditional | PDF ↗ |
| K933437 | DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3 | Baxter Diagnostics, Inc. | 1993-10-28 | Traditional | PDF ↗ |
| K934357 | LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2 | Bio-Rad | 1993-10-21 | Traditional | PDF ↗ |
| K934056 | TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3 | Medical Analysis Systems, Inc. | 1993-10-18 | Traditional | PDF ↗ |
| K933435 | DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2 | Baxter Diagnostics, Inc. | 1993-09-24 | Traditional | PDF ↗ |
| K930850 | BECKMAN VIGIL PLUS CONTROL | Beckman Instruments, Inc. | 1993-09-01 | Traditional | PDF ↗ |
| K933317 | LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 | Bio-Rad | 1993-08-11 | Traditional | PDF ↗ |
| K924919 | DADE(R) TUMOR MARKER CONTROL | Baxter Diagnostics, Inc. | 1993-08-05 | Traditional | PDF ↗ |
| K931366 | TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3 | Medical Analysis Systems, Inc. | 1993-07-28 | Traditional | PDF ↗ |
| K932458 | DOCUMENT ENZYME | Casco Standards | 1993-06-29 | Traditional | PDF ↗ |
| K932076 | LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II | Bio-Rad | 1993-06-29 | Traditional | PDF ↗ |
| K923663 | MULTITROL IMMUNOLOGY CONTROL | Behring Diagnostics, Inc. | 1993-06-28 | Traditional | PDF ↗ |
Product code JJY · Class I · Clinical Chemistry. Data: openFDA.