FDA Product Code
FDA Product Code JJT — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1660
510(k) Clearances — 97 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K090940 | SPOTCHECK BLOOD SPOT CONTROL, ASSAYED | Astoria-Pacific, Inc. | 2009-12-14 | Traditional | PDF ↗ |
| K062751 | MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER | Quantimetrix Corp. | 2006-10-03 | Special | PDF ↗ |
| K030768 | CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL | Cliniqa Corporation | 2003-03-21 | Traditional | PDF ↗ |
| K030102 | ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 | Bayer Healthcare, LLC | 2003-01-24 | Abbreviated | PDF ↗ |
| K021498 | LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL | Bio-Rad | 2002-05-24 | Traditional | PDF ↗ |
| K012656 | LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 | Bio-Rad | 2001-09-06 | Traditional | PDF ↗ |
| K993723 | CARDIASURE CARDIAC MARKERS CONTROL | Quantimetrix Corp. | 1999-11-23 | Traditional | PDF ↗ |
| K993715 | QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 | Seracare Technology | 1999-11-16 | Traditional | PDF ↗ |
| K992430 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 | Medical Analysis Systems, Inc. | 1999-08-30 | Traditional | PDF ↗ |
| K984437 | QUANTEX ASO-CRP-RP CONTROL II | Instrumentation Laboratory CO | 1999-02-02 | Traditional | PDF ↗ |
| K984277 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 | Medical Analysis Systems, Inc. | 1998-12-09 | Traditional | PDF ↗ |
| K982845 | CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 | More Diagnostics | 1998-08-21 | Traditional | PDF ↗ |
| K980556 | LIQUICHEK CARDIAC MARKERS CONTROL LT | Bio-Rad | 1998-02-25 | Traditional | PDF ↗ |
| K974461 | TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL | Biosite Incorporated | 1997-12-10 | Traditional | PDF ↗ |
| K973974 | DADE TRU-LIQUID CARDIAC CONTROL | Dade Intl., Inc. | 1997-11-06 | Traditional | PDF ↗ |
| K972976 | CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL | More Diagnostics | 1997-08-29 | Traditional | PDF ↗ |
| K972408 | CARDIAC STATUS CONTROLS | Spectral Diagnostics, Inc. | 1997-07-25 | Traditional | PDF ↗ |
| K971777 | QUANTEX ASO-CRP-RF CONTROL | Instrumentation Laboratory CO | 1997-05-27 | Traditional | PDF ↗ |
| K970856 | CARDIOISOZYME, CK/LD ISOENZYME CONTROL | Medical Analysis Systems, Inc. | 1997-04-08 | Traditional | PDF ↗ |
| K965169 | STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003) | Specialized Assays, Inc. | 1997-02-06 | Traditional | PDF ↗ |
| K965168 | STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002) | Specialized Assays, Inc. | 1997-02-04 | Traditional | PDF ↗ |
| K965166 | STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) | Specialized Assays, Inc. | 1997-02-04 | Traditional | PDF ↗ |
| K961828 | LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) | Bio-Rad | 1996-06-11 | Traditional | PDF ↗ |
| K960275 | OPUS CK-MB & TOTAL CK CONTROLS | Behring Diagnostics, Inc. | 1996-04-25 | Traditional | PDF ↗ |
| K960246 | LIQUID CARDIAC MARKER 1,2,3 ASSAYED | Ciba Corning Diagnostics Corp. | 1996-04-23 | Traditional | PDF ↗ |
| K950803 | ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE | Isolab, Inc. | 1995-09-21 | Traditional | PDF ↗ |
| K951293 | QUANTITATE ENZYME VERIFIER SET | Beckman Instruments, Inc. | 1995-04-20 | Traditional | PDF ↗ |
| K950801 | CARDIO REP LD CONTROL - CAT NO. 3325 | Helena Laboratories | 1995-03-30 | Traditional | PDF ↗ |
| K946146 | CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION | Clinical Controls, Inc. | 1995-01-24 | Traditional | PDF ↗ |
| K946145 | CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL | Clinical Controls, Inc. | 1995-01-24 | Traditional | PDF ↗ |
| K944923 | CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3, | Clinical Controls, Inc. | 1994-11-04 | Traditional | PDF ↗ |
| K944246 | CARDIOCHEX CKMB MASS MEASUREMENT CONTROL | Cala Diagnostics | 1994-10-31 | Traditional | PDF ↗ |
| K944247 | CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL | Cala Diagnostics | 1994-10-31 | Traditional | PDF ↗ |
| K944243 | CARDIOCHEX | Cala Diagnostics | 1994-10-27 | Traditional | PDF ↗ |
| K943684 | HICHEM ENZYME VERIFIER KIT | Hi Chem, Inc. | 1994-10-04 | Traditional | PDF ↗ |
| K932442 | CARDIO REP RECOMBINANT CK ABNORMAL CONTROL | Helena Laboratories | 1993-10-28 | Traditional | PDF ↗ |
| K930889 | ROCHE CARDIOTROL-CK | Roche Diagnostic Systems, Inc. | 1993-07-06 | Traditional | PDF ↗ |
| K930875 | CKMB CONTROL - LEVEL 1,2,3 | Cala Diagnostics | 1993-04-13 | Traditional | PDF ↗ |
| K930873 | CKMB ISOENZYME CONTROL-LEVEL 1,2.3 | Cala Diagnostics | 1993-04-13 | Traditional | PDF ↗ |
| K925151 | LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3 | Bio-Rad | 1992-12-17 | Traditional | PDF ↗ |
| K905623 | CK-MB IMMUNOASSAY CONTROL | Seradyn, Inc. | 1991-02-22 | Traditional | PDF ↗ |
| K903430 | LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2 | Bio-Rad | 1990-08-23 | Traditional | PDF ↗ |
| K902321 | HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235) | Hichem Diagnostics | 1990-06-28 | Traditional | PDF ↗ |
| K896465 | CLP CK/LD ISOENZYME/IMMUNO CONTROL | Creative Laboratory Products, Inc. | 1990-03-01 | Traditional | PDF ↗ |
| K894554 | CLP CK/LD ISOENZYME CONTROL | Creative Laboratory Products, Inc. | 1989-10-16 | Traditional | PDF ↗ |
| K894207 | CK-MB/LD-1 CONTROL SYSTEM | Boehringer Mannheim Corp. | 1989-08-28 | Traditional | PDF ↗ |
| K883395 | ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY | Quantimetrix Medical Industries | 1988-09-19 | Traditional | PDF ↗ |
| K882795 | DADE(R) CK-MB IMMUNOASSAY CONTROL | Baxter Healthcare Corp | 1988-08-29 | Traditional | PDF ↗ |
| K880701 | QUANTIMETRIX SERUM ENZYME CONTROL | Quantimetrix Corp. | 1988-03-24 | Traditional | PDF ↗ |
| K880266 | MULTI-ENZYME LINEARITY SOLUTION | Verichem Laboratories, Inc. | 1988-02-18 | Traditional | PDF ↗ |
| K874302 | QUANTIMETRIX TOTAL CREATINE KINASE CONTROL | Quantimetrix Medical Industries | 1988-02-02 | Traditional | PDF ↗ |
| K874141 | TITAN GEL REP CPK/LDH ISOENZYME CONTROL | Helena Laboratories | 1987-11-04 | Traditional | PDF ↗ |
| K872646 | VIRON(TM) | bioMerieux, Inc. | 1987-09-14 | Traditional | PDF ↗ |
| K870737 | U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL | U. S. Diagnostics, Inc. | 1987-04-13 | Traditional | PDF ↗ |
| K870738 | U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL | U. S. Diagnostics, Inc. | 1987-04-13 | Traditional | PDF ↗ |
| K861506 | DOCUMENT ENZYME LINEARITY TEST SETS | Casco Standards | 1986-06-13 | Traditional | PDF ↗ |
| K861512 | EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95 | Em Diagnostic Systems, Inc. | 1986-05-23 | Traditional | PDF ↗ |
| K861329 | ISOTRAK AMYLASE ISOENZYME CONTROL SET | Behring Diagnostics, Inc. | 1986-04-30 | Traditional | PDF ↗ |
| K860764 | EMDS ENZYME VERIFIER, LEVELS I & II | Em Diagnostic Systems, Inc. | 1986-04-07 | Traditional | PDF ↗ |
| K855006 | CANTROL CK/MB CONTROL | Canyon Diagnostics, Inc. | 1986-01-17 | Traditional | PDF ↗ |
| K854973 | V-TREND OC CPK | V-Tech, Inc. | 1986-01-13 | Traditional | PDF ↗ |
| K853373 | DELTA TROL I & II | Electro-Nucleonics Laboratories, Inc. | 1985-08-23 | Traditional | PDF ↗ |
| K850907 | CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ | Cala Diagnostics | 1985-06-25 | Traditional | PDF ↗ |
| K851520 | CK/LD ISOENZYMES CONTROLS(HUMAN) | Seragen Diagnostics, Inc. | 1985-06-25 | Traditional | PDF ↗ |
| K850213 | ISOCONTROL SERUM CK-MB | Sclavo, Inc. | 1985-03-05 | Traditional | PDF ↗ |
| K850211 | ISOCONTROL SERUM LD- | Sclavo, Inc. | 1985-02-07 | Traditional | PDF ↗ |
| K843265 | ID ZINE LD ISOENZYME CONTROL ABNORM | Beckman Instruments, Inc. | 1984-09-13 | Traditional | PDF ↗ |
| K843266 | ID ZONE NORMAL LD ISOENZYME CONTROL | Beckman Instruments, Inc. | 1984-09-13 | Traditional | PDF ↗ |
| K840793 | CK/MB IMMUNO-ISOENZYME CONTROL SERUM | Seragen Diagnostics, Inc. | 1984-04-13 | Traditional | PDF ↗ |
| K822984 | ID-ZONE LD ISOENZYME CONTROL | Beckman Instruments, Inc. | 1982-11-10 | Traditional | PDF ↗ |
| K822646 | QUANTAPHOS ACID PHOSPHATOSE CONT. SERUM | Beckman Instruments, Inc. | 1982-09-30 | Traditional | PDF ↗ |
| K821981 | TITAN GEL CPK/LDH ISOENZYME CONTROL | Helena Laboratories | 1982-07-22 | Traditional | PDF ↗ |
| K821183 | TARGET ISOCHECK CONTROL SERUM | Smithkline Diagnostics, Inc. | 1982-05-14 | Traditional | PDF ↗ |
| K820360 | AALTO LDH ISOENZYME CONTROL SERUM | Aalto Scientific, Ltd. | 1982-03-04 | Traditional | PDF ↗ |
| K812671 | EMBRITROL CK-MB CONTROLS | Intl. Immunoassay Laboratories, Inc. | 1981-10-02 | Traditional | PDF ↗ |
| K810870 | GEMENI CK-MB ISOENZYME ABNORMAL SERUM | Gemini, Inc. | 1981-04-14 | Traditional | PDF ↗ |
| K810725 | QUALITROL #65057 | Harleco | 1981-03-31 | Traditional | PDF ↗ |
| K803305 | DUPONT 'ACA' CREATINE KINASE VERIFIERS | E.I. Dupont DE Nemours & Co., Inc. | 1981-01-16 | Traditional | PDF ↗ |
| K800604 | CK ISOENZYME ELECTROPHORESIS CONTROL-I.D | Beckman Instruments, Inc. | 1980-04-10 | Traditional | PDF ↗ |
| K791723 | QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN) | Organon, Inc. | 1979-10-01 | Traditional | PDF ↗ |
| K791299 | CPK ISOENZYME CONTROL | Electrophoresis Corp. of America | 1979-08-16 | Traditional | PDF ↗ |
| K791300 | LDH ISOENZYME CONTROL | Electrophoresis Corp. of America | 1979-08-16 | Traditional | PDF ↗ |
| K790985 | P.A.P. RIA CONTROL SERUM PACK | Mallinckrodt Critical Care | 1979-07-17 | Traditional | PDF ↗ |
| K781100 | DELTA TEST AMYLASE/LIPASE CONTS. I,II | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-14 | Traditional | PDF ↗ |
| K780801 | ISOZYME - ID CPK MARKER | Dade, Baxter Travenol Diagnostics, Inc. | 1978-06-13 | Traditional | PDF ↗ |
| K780554 | CLIN. CHEM. CONTROL SERUM-QUANTITATE | Beckman Instruments, Inc. | 1978-06-06 | Traditional | PDF ↗ |
| K780204 | CHEMISTRY CONTROL & REFERENCE SERUMS | Hyland Therapeutic Div., Travenol Laboratories | 1978-03-03 | Traditional | PDF ↗ |
| K780147 | ISOENZYME SERUM CONTROL | Corning Medical & Scientific | 1978-02-23 | Traditional | PDF ↗ |
| K771800 | ACA GLUTAMYL TRANSFERASE | E.I. Dupont DE Nemours & Co., Inc. | 1977-10-25 | Traditional | PDF ↗ |
| K771740 | CARDIOZYME CK-CONTROL LEVEL 1 | Dade, Baxter Travenol Diagnostics, Inc. | 1977-10-19 | Traditional | PDF ↗ |
| K771436 | SERONORM | Nyegaard & Co. A/S | 1977-09-02 | Traditional | PDF ↗ |
| K771439 | PATHONORM H & L | Nyegaard & Co. A/S | 1977-09-02 | Traditional | PDF ↗ |
| K771438 | AUTONORM | Nyegaard & Co. A/S | 1977-09-02 | Traditional | PDF ↗ |
| K770973 | CARDIOZYME CK CONTROL NORMAL | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-04 | Traditional | PDF ↗ |
| K770971 | CARDIOZYME CK-CONTROL ABNORMAL | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-04 | Traditional | PDF ↗ |
| K770555 | CPK ISOENZYME CONTROL | Bio-Reagents & Diagnostics, Inc. | 1977-06-03 | Traditional | PDF ↗ |
| K770049 | LDH ISOTROL T | Sigma Chemical Co. | 1977-01-26 | Traditional | PDF ↗ |
Product code JJT · Class I · Clinical Chemistry. Data: openFDA.