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 6 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K882736 | AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA | Amersham Corp. | 1988-10-11 | Traditional | PDF ↗ |
| K883147 | TRACE ELEMENTS SERUM TOXICOLOGY CONTROL | Utak Laboratories, Inc. | 1988-10-06 | Traditional | PDF ↗ |
| K882728 | AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190 | Amersham Corp. | 1988-10-06 | Traditional | PDF ↗ |
| K883124 | AMERLITE FREE THYROID CONTROL SERA LAN.4002 | Amersham Corp. | 1988-09-30 | Traditional | PDF ↗ |
| K883247 | LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL | Quantimetrix Medical Industries | 1988-09-13 | Traditional | PDF ↗ |
| K883012 | A.QC CHEMISTRY CONTROL LEVEL 2 | Arden Medical Systems, Inc. | 1988-09-09 | Traditional | PDF ↗ |
| K882727 | AMERLITE TOTAL THYROID CONTROL SERA LAN.4001 | Amersham Corp. | 1988-08-08 | Traditional | PDF ↗ |
| K882542 | LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II | Bio-Rad | 1988-07-21 | Traditional | PDF ↗ |
| K881503 | MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL | Baxter Healthcare Corp | 1988-07-08 | Traditional | PDF ↗ |
| K881437 | CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS | Hichem Diagnostics | 1988-07-06 | Traditional | PDF ↗ |
| K881438 | UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN | Hichem Diagnostics | 1988-07-06 | Traditional | PDF ↗ |
| K881113 | CLP LIPOPROTEIN ELECTROPHORESIS CONTROL | Creative Laboratory Products, Inc. | 1988-07-01 | Traditional | PDF ↗ |
| K881436 | SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS | Hichem Diagnostics | 1988-06-02 | Traditional | PDF ↗ |
| K880447 | MULTI-FUNCTION BLOOD GAS CONTROL | Bionostics, Inc. | 1988-05-27 | Traditional | PDF ↗ |
| K881229 | AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693 | Em Diagnostic Systems, Inc. | 1988-05-27 | Traditional | PDF ↗ |
| K881275 | URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II | Fisher Scientific Co., LLC | 1988-05-16 | Traditional | PDF ↗ |
| K880494 | LYPHOCHEK SPINAL FLUID CONTROL (HUMAN) | Bio-Rad | 1988-03-03 | Traditional | PDF ↗ |
| K880175 | DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL | Baxter Healthcare Corp | 1988-03-01 | Traditional | PDF ↗ |
| K874731 | LYPHOCHEK WHOLE BLOOD CONTROL | Bio-Rad | 1988-02-18 | Traditional | PDF ↗ |
| K874280 | LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II | Bio-Rad | 1988-01-21 | Traditional | PDF ↗ |
| K874809 | REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM | Biotrol, USA, Inc. | 1988-01-07 | Traditional | PDF ↗ |
| K874810 | REFERENCE ASSAYED CHEMISTRY CONTROL SERUM | Biotrol, USA, Inc. | 1988-01-05 | Traditional | PDF ↗ |
| K874772 | DC-TROL LEVEL 1 OR 2 | Diagnostic Chemicals, Ltd. (Usa) | 1988-01-05 | Traditional | PDF ↗ |
| K874459 | LIQUI-SERA SPINAL FLUID CONTROL | Biodiagnostic Intl | 1987-12-29 | Traditional | PDF ↗ |
| K874230 | PRECINORM L | Boehringer Mannheim Corp. | 1987-11-23 | Traditional | PDF ↗ |
| K873611 | A-QC CLINICAL CHEMISTRY CONTROL | Arden Medical Systems, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K872777 | BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL | Biotrol, USA, Inc. | 1987-08-26 | Traditional | PDF ↗ |
| K872785 | BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM | Biotrol, USA, Inc. | 1987-08-26 | Traditional | PDF ↗ |
| K872376 | LIPID CONTROL SERUM | Biological Industries | 1987-08-05 | Traditional | PDF ↗ |
| K871977 | DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR | American Dade | 1987-07-09 | Traditional | PDF ↗ |
| K872304 | UNASSAYED CONTROL SERUM, NORMAL (BOVINE) | Vanguard Diagnostic Systems | 1987-07-07 | Traditional | PDF ↗ |
| K872303 | UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE) | Vanguard Diagnostic Systems | 1987-07-07 | Traditional | PDF ↗ |
| K872227 | LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II | Bio-Rad | 1987-07-06 | Traditional | PDF ↗ |
| K871342 | QM2/QM300 CONTROL A PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-05-21 | Traditional | PDF ↗ |
| K871537 | CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II | Canyon Diagnostics, Inc. | 1987-05-06 | Traditional | PDF ↗ |
| K870684 | LIQUID CHEMISTRY CONTROL, LEVEL I | U. S. Diagnostics, Inc. | 1987-04-06 | Traditional | PDF ↗ |
| K870683 | LIQUID CHEMISTRY CONTROL, LEVEL II | U. S. Diagnostics, Inc. | 1987-04-06 | Traditional | PDF ↗ |
| K871058 | SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) | Fisher Scientific Co., LLC | 1987-04-06 | Traditional | PDF ↗ |
| K870252 | DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET | Casco Standards | 1987-02-20 | Traditional | PDF ↗ |
| K862565 | CHEMTROL(TM) | G.B.F. Industries, Inc. | 1987-01-13 | Traditional | PDF ↗ |
| K861202 | TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS | Nms Pharmaceuticals, Inc. | 1987-01-09 | Traditional | PDF ↗ |
| K863751 | MULTI-ANALYTE LIN-TROL | Sigma Diagnostics, Inc. | 1986-11-24 | Traditional | PDF ↗ |
| K863849 | LIQUI-SERA COMBO LIGAND/TDM CONTROLS | Biodiagnostic Intl | 1986-11-24 | Traditional | PDF ↗ |
| K863648 | SERACON CT REFERENCE | Bhp Diagnostix, Inc. | 1986-10-29 | Traditional | PDF ↗ |
| K863745 | ABNORMAL SPINAL FLUID CONTROL | Ciba Corning Diagnostics Corp. | 1986-10-07 | Traditional | PDF ↗ |
| K861420 | QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL | Quantimetrix Corp. | 1986-09-16 | Traditional | PDF ↗ |
| K862963 | THERAPEUTIC DRUG MONITORING CONTROL SET | American Monitor Corp. | 1986-09-15 | Traditional | PDF ↗ |
| K862420 | UTAK-STABBS TOXICOLOGY CONTROL | Utak Laboratories, Inc. | 1986-08-04 | Traditional | PDF ↗ |
| K862586 | CHEMVARION(TM) | G.B.F. Industries, Inc. | 1986-08-04 | Traditional | PDF ↗ |
| K862185 | LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL | Bio-Rad | 1986-08-04 | Traditional | PDF ↗ |
| K862278 | GAS-TRAK | United Diagnostics, Inc. | 1986-08-04 | Traditional | PDF ↗ |
| K862587 | CHEMTROL(TM) | G.B.F. Industries, Inc. | 1986-08-04 | Traditional | PDF ↗ |
| K860999 | GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED | Ciba Corning Diagnostics Corp. | 1986-07-02 | Traditional | PDF ↗ |
| K862179 | SOMAS LIQUID URINE CONTROL | Somas Medical Industries, Inc. | 1986-07-01 | Traditional | PDF ↗ |
| K861901 | MULTI-4 CO-OXIMETER CONTROL | Allied Instrumentation Laboratory | 1986-06-17 | Traditional | PDF ↗ |
| K860906 | STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III | American Dade | 1986-05-29 | Traditional | PDF ↗ |
| K861567 | CONTROL SERA LEVEL VALUES (MG/DL) | E.I. Dupont DE Nemours & Co., Inc. | 1986-05-23 | Traditional | PDF ↗ |
| K861185 | THERACHEM-PLUS, TRI-LEVEL TDC (TM) | Fisher Scientific Co., LLC | 1986-05-23 | Traditional | PDF ↗ |
| K861603 | IRON PROCEDURE | Data Medical Associates, Inc. | 1986-05-23 | Traditional | PDF ↗ |
| K860942 | QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID | Quantimetrix Corp. | 1986-05-23 | Traditional | PDF ↗ |
| K861448 | QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID | Quantimetrix Medical Industries | 1986-04-28 | Traditional | PDF ↗ |
| K861068 | GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED | Ciba Corning Diagnostics Corp. | 1986-04-07 | Traditional | PDF ↗ |
| K860970 | PRECINORM IM AND PRECIPATH IM | Boehringer Mannheim Corp. | 1986-04-03 | Traditional | PDF ↗ |
| K860998 | GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED | Ciba Corning Diagnostics Corp. | 1986-04-03 | Traditional | PDF ↗ |
| K861000 | GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED | Ciba Corning Diagnostics Corp. | 1986-04-03 | Traditional | PDF ↗ |
| K860355 | BOVINE CHEMISTRY CONTROL I.X AND II.X | American Dade | 1986-03-17 | Traditional | PDF ↗ |
| K855036 | CHEMISTRY CONTROL N & A | Integrated Medical Systems Int'L., Inc. | 1986-03-17 | Traditional | PDF ↗ |
| K855035 | CALIBRATION REFERENCE I & II | Integrated Medical Systems Int'L., Inc. | 1986-03-17 | Traditional | PDF ↗ |
| K854931 | CANTROL ELECTROPHORESIS CONTROL | Canyon Diagnostics, Inc. | 1986-01-17 | Traditional | PDF ↗ |
| K854789 | RANGE-CHEK | American Monitor Corp. | 1986-01-13 | Traditional | PDF ↗ |
| K854967 | CRITIC - SF, ASSAYED | Dimension Diagnostics | 1986-01-07 | Traditional | PDF ↗ |
| K853943 | CRITIC C LEVEL I & II | Dimension Diagnostics | 1985-12-23 | Traditional | PDF ↗ |
| K854119 | ACCURACY | Columbia Diagnostics, Inc. | 1985-10-25 | Traditional | PDF ↗ |
| K853931 | QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL | Quantimetrix Corp. | 1985-10-04 | Traditional | PDF ↗ |
| K853906 | LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) | Biodiagnostic Intl | 1985-10-04 | Traditional | PDF ↗ |
| K852753 | DC LIQUITROL LEVEL 1 & 2 | Diagnostic Chemicals, Ltd. (Usa) | 1985-08-02 | Traditional | PDF ↗ |
| K852418 | QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL) | Amf Biological and Diagnostics Co. | 1985-07-15 | Traditional | PDF ↗ |
| K851820 | SPINAL FLUID CONTROL | Irvine Scientific | 1985-07-15 | Traditional | PDF ↗ |
| K852594 | DC-LIP, CATALOGUE NUMBER SE-020 | Diagnostic Chemicals, Ltd. (Usa) | 1985-07-12 | Traditional | PDF ↗ |
| K851942 | COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY | Coulter Electronics, Inc. | 1985-05-31 | Traditional | PDF ↗ |
| K850574 | DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO | American Dade | 1985-04-12 | Traditional | PDF ↗ |
| K850575 | DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H | American Dade | 1985-04-10 | Traditional | PDF ↗ |
| K850017 | PRECINORM H & PRECIPATH H | Boehringer Mannheim Corp. | 1985-03-05 | Traditional | PDF ↗ |
| K844848 | IMA-TROL IMMUNOASSAY CONTROL | Dimension Diagnostics | 1985-03-01 | Traditional | PDF ↗ |
| K844413 | ULTROSER G | Lkb Instruments, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K844996 | PARAGON TRICHECK ELECTROPHORESIS CONTROL | Beckman Instruments, Inc. | 1985-02-06 | Traditional | PDF ↗ |
| K850202 | GELMAN TRIPHOR CONTROL | Gelman Sciences, Inc. | 1985-02-06 | Traditional | PDF ↗ |
| K844125 | LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN | Bio-Rad | 1985-01-08 | Traditional | PDF ↗ |
| K844760 | UROL-QUAL | Dimension Diagnostics | 1985-01-08 | Traditional | PDF ↗ |
| K844018 | GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 | United Diagnostics, Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K843986 | STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3 | United Diagnostics, Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K843611 | QUALIFY I & II AMER. MONITOR 2009 & 2010 | American Monitor Corp. | 1984-09-28 | Traditional | PDF ↗ |
| K842970 | ALLERGENTICS TOTAL IGE/THEOPHYLLINE | Allergenetics | 1984-08-29 | Traditional | PDF ↗ |
| K841884 | KODAK EKTACHEM CONTROL | Eastman Kodak Company | 1984-07-06 | Traditional | PDF ↗ |
| K841452 | NOVA STAT CONTROL LEVELS 1/2/3 | Nova Biomedical Corp. | 1984-06-22 | Traditional | PDF ↗ |
| K840458 | BIOTIS ABNORMAL CLINICAL CHEM SERUM- | Otisville Biotech, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K840457 | NORMAL CLINICAL CHEM. CONTROL SERUM- | Otisville Biotech, Inc. | 1984-04-13 | Traditional | PDF ↗ |
| K834064 | ORTHO BI-LEVEL RECEPTOR CONTROL | Ortho Diagnostic Systems, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K833009 | OMNI-FAL I & II | American Monitor Corp. | 1984-01-13 | Traditional | PDF ↗ |
| K833639 | TITANGEL HIGH RESOLUTION CONTROL | Helena Laboratories | 1984-01-04 | Traditional | PDF ↗ |
Product code JJY · Class I · Clinical Chemistry. Data: openFDA.