FDA Product Code
FDA Product Code CGS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1215
510(k) Clearances — 123 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K191296 | Pointe Scientific Creatinine Kinase (CK) Reagent Set | Medtest DX | 2020-08-11 | Traditional | PDF ↗ |
| K182702 | SEKURE Creatine Kinase Assay | Sekisui Diagnostics P.E.I., Inc. | 2019-04-17 | Traditional | PDF ↗ |
| K160724 | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator | Siemens Healthcare Diagnostics, Inc. | 2016-09-07 | Traditional | PDF ↗ |
| K123977 | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR | Randox Laboratories, Ltd. | 2013-11-21 | Traditional | PDF ↗ |
| K112416 | CPK REAGENT | Vital Diagnostics (Manufacturing) Ptyltd | 2011-11-09 | Traditional | PDF ↗ |
| K083465 | DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | 2009-02-27 | Special | PDF ↗ |
| K081731 | DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 | Siemens Healthcare Diagnostics | 2008-08-29 | Traditional | PDF ↗ |
| K072548 | CREATINE KINASE LIQUID REAGENT, MODEL C519-440 | Teco Diagnostics | 2008-04-18 | Traditional | PDF ↗ |
| K062737 | CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | Horiba Abx | 2007-06-12 | Traditional | PDF ↗ |
| K051648 | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS | Arkray, Inc. | 2006-01-31 | Traditional | PDF ↗ |
| K043202 | OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 | Olympus America, Inc. | 2004-12-23 | Traditional | PDF ↗ |
| K021332 | WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA | Wiener Laboratories Saic | 2002-07-03 | Traditional | PDF ↗ |
| K013912 | CREATINE KINASE (CK-NAC) | Jas Diagnostics, Inc. | 2002-01-18 | Traditional | PDF ↗ |
| K012474 | ATAC PAK CPK REAGENT KIT | Elan Holdings, Inc. | 2001-10-03 | Traditional | PDF ↗ |
| K994189 | OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 | Olympus Diagnostica GmbH | 2000-01-20 | Traditional | PDF ↗ |
| K992148 | HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT | Morax | 1999-12-29 | Traditional | PDF ↗ |
| K983070 | CK | Abbott Laboratories | 1999-02-16 | Traditional | PDF ↗ |
| K981218 | CREATINE KINASE (CK) | Abbott Laboratories | 1998-05-01 | Traditional | PDF ↗ |
| K980900 | N-ASSAY CPK-L | Crestat Diagnostics, Inc. | 1998-03-26 | Traditional | PDF ↗ |
| K973999 | CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 | Diagnostic Chemicals , Ltd. | 1998-03-11 | Traditional | PDF ↗ |
| K974833 | CK-NAC REAGENT | Intersect Systems, Inc. | 1998-02-13 | Traditional | PDF ↗ |
| K972155 | CREATINE KINASE (CK) | Stanbio Laboratory | 1997-07-17 | Traditional | PDF ↗ |
| K971566 | CREATINE KINASE-MB REAGENT SET | Horizon Diagnostics, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K971396 | CK REAGENT | Carolina Liquid Chemistries Corp. | 1997-05-29 | Traditional | PDF ↗ |
| K962247 | HICHEM CK/NAC REAGENT KIT | Elan Pharma, Inc. | 1996-08-15 | Traditional | PDF ↗ |
| K951223 | CK-MB (NAC-ACT) | Randox Laboratories, Ltd. | 1995-12-26 | Traditional | PDF ↗ |
| K952745 | CREATINE KINASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-11 | Traditional | PDF ↗ |
| K952646 | IL TEST CK-MB | Instrumentation Laboratory CO | 1995-08-04 | Traditional | PDF ↗ |
| K950177 | CK QVET | Prisma Systems | 1995-03-03 | Traditional | PDF ↗ |
| K942773 | CK-MB ASSAY, CATALOGUE NUMBER 317-10 | Diagnostic Chemicals , Ltd. | 1994-08-24 | Traditional | PDF ↗ |
| K935463 | CREATINE KINASE-MB (CK-MB) REAGENT SET | Pointe Scientific, Inc., | 1994-01-11 | Traditional | PDF ↗ |
| K933675 | OPUS TOTAL CK | Pb Diagnostic Systems, Inc. | 1993-09-08 | Traditional | PDF ↗ |
| K931889 | CREATINE KINASE TEST | Em Diagnostic Systems, Inc. | 1993-07-27 | Traditional | PDF ↗ |
| K931326 | KING DIAGNOSTICS CK REAGENT | King Diagnostics, Inc. | 1993-06-15 | Traditional | PDF ↗ |
| K930932 | SYNERMED CREATINE KINASE REAGENT KIT | Synermed, Inc. | 1993-05-11 | Traditional | PDF ↗ |
| K930660 | CREATINE KINASE (CK) REAGENT SET | Pointe Scientific, Inc., | 1993-03-29 | Traditional | PDF ↗ |
| K924832 | OLYMPUS CREATINE KINASE REAGENT | Olympus Corp. | 1993-01-04 | Traditional | PDF ↗ |
| K925801 | REP E-Z CK-30 ISOENZYME KIT | Helena Laboratories | 1992-12-28 | Traditional | PDF ↗ |
| K923511 | CK-NAC ACTIVATED KIT | Randox Laboratories, Ltd. | 1992-10-15 | Traditional | PDF ↗ |
| K924704 | CREATINE KINASE (CK) TEST ITEM #65411 | Em Diagnostic Systems, Inc. | 1992-10-13 | Traditional | PDF ↗ |
| K922459 | OLYMPUS CREATINE KINASE REAGENT | Olympus Corp. | 1992-07-13 | Traditional | PDF ↗ |
| K915709 | CREATINE KINASE-MB (CK-MB) REAGENT SET | Tech Intl. Co. | 1992-01-27 | Traditional | PDF ↗ |
| K914361 | CREATINE KINASE MB TEST ITEM NUMBER 5A46 | Em Diagnostic Systems, Inc. | 1991-12-13 | Traditional | PDF ↗ |
| K913398 | RAICHEM(TM) CREATINE KINASE-MB REAGENT | Reagents Applications, Inc. | 1991-09-25 | Traditional | PDF ↗ |
| K905084 | RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV | Reagents Applications, Inc. | 1990-12-20 | Traditional | PDF ↗ |
| K904004 | AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116 | Amresco, Inc. | 1990-12-11 | Traditional | PDF ↗ |
| K903775 | CREATINE PHOSPHOKINASE | Amresco, Inc. | 1990-10-04 | Traditional | PDF ↗ |
| K904102 | REFLOTRON CREATINE KINASE TEST TABS | Boehringer Mannheim Corp. | 1990-09-27 | Traditional | PDF ↗ |
| K903333 | CREATINE KINASE TEST (CK) ITEM NUMBER 65411 | Em Diagnostic Systems, Inc. | 1990-08-17 | Traditional | PDF ↗ |
| K902483 | CREATINE KINASE-MB TEST (MB-DS) ITEM #67655 | Em Diagnostic Systems, Inc. | 1990-07-10 | Traditional | PDF ↗ |
| K901267 | COULTER CK (CREATINE KINASE) REAGENT | Coulter Corp. | 1990-05-23 | Traditional | PDF ↗ |
| K894715 | CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS | Catachem, Inc. | 1989-11-08 | Traditional | PDF ↗ |
| K893691 | EMDS CREATINE KINASE ITEM NIMBER 65411 | Diagnostic Systems | 1989-08-31 | Traditional | PDF ↗ |
| K893007 | REP(TM) CK-2 STAT KIT, CAT. NO. 3074 | Helena Laboratories | 1989-07-20 | Traditional | PDF ↗ |
| K893269 | BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME | Beckman Instruments, Inc. | 1989-07-20 | Traditional | PDF ↗ |
| K891462 | ROCHE(R) CARDIOSCREEN-CK | Roche Diagnostic Systems, Inc. | 1989-05-22 | Traditional | PDF ↗ |
| K891470 | CK-NAC 2-VIAL REAGENT W/SUBSTRATE START | Trace Scientific , Ltd. | 1989-05-09 | Traditional | PDF ↗ |
| K890609 | IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) | Intl. Immunoassay Laboratories, Inc. | 1989-03-16 | Traditional | PDF ↗ |
| K890540 | ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC | Abbott Laboratories | 1989-02-27 | Traditional | PDF ↗ |
| K884547 | CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673 | Em Diagnostic Systems, Inc. | 1989-02-10 | Traditional | PDF ↗ |
| K884546 | CREATINE KINASE TEST (CK) ITEM NUMBER: 65661 | Em Diagnostic Systems, Inc. | 1989-02-02 | Traditional | PDF ↗ |
| K883946 | VISION CREATINE KINASE | Abbott Laboratories | 1988-10-13 | Traditional | PDF ↗ |
| K883504 | DURAZYME(R) CPK | American Monitor Corp. | 1988-09-13 | Traditional | PDF ↗ |
| K873201 | WAKO(TM) AUTOKIT CK-NAC | Wako Chemicals USA, Inc. | 1987-11-05 | Traditional | PDF ↗ |
| K874146 | TITAN GEL REP CPK-12 HV | Helena Laboratories | 1987-11-05 | Traditional | PDF ↗ |
| K874139 | TITAN GEL REP CPK-30 HV | Helena Laboratories | 1987-11-03 | Traditional | PDF ↗ |
| K874140 | TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED. | Helena Laboratories | 1987-11-03 | Traditional | PDF ↗ |
| K873134 | UNIFAST CK-MB | Sclavo, Inc. | 1987-09-16 | Traditional | PDF ↗ |
| K870462 | EASY-TEST CREATINE KINASE-MB (CK-MB) #16615 | Em Diagnostic Systems, Inc. | 1987-03-10 | Traditional | PDF ↗ |
| K870461 | EASY-TEST CREATINE KINASE (CK) NUMBER: 16614 | Em Diagnostic Systems, Inc. | 1987-03-06 | Traditional | PDF ↗ |
| K864359 | CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) | Trace Scientific , Ltd. | 1987-02-06 | Traditional | PDF ↗ |
| K864744 | CREATINE PHOSPHOKINASE (CK) | Tech-Co, Inc. | 1987-01-13 | Traditional | PDF ↗ |
| K863587 | CREATINE PHOSPHOKINASE(CK) PROCEDURE | Data Medical Associates, Inc. | 1986-10-03 | Traditional | PDF ↗ |
| K861665 | CREATINE PHROSPHOKINASE (CK) PROCEDURE | Data Medical Associates, Inc. | 1986-06-05 | Traditional | PDF ↗ |
| K861879 | CK REAGENT CARTRIDGE (PRODUCT NO. 88213) | Hi Chem, Inc. | 1986-05-29 | Traditional | PDF ↗ |
| K860733 | CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE | Trace Scientific , Ltd. | 1986-04-24 | Traditional | PDF ↗ |
| K861061 | EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK | Em Diagnostic Systems, Inc. | 1986-04-24 | Traditional | PDF ↗ |
| K860669 | CREATINE KINASE, N-ACETYL-L-CYSTIENE | Em Diagnostic Systems, Inc. | 1986-04-07 | Traditional | PDF ↗ |
| K860096 | CPK REAGENT SET (COLORIMETRIC) | Sterling Diagnostics, Inc. | 1986-02-11 | Traditional | PDF ↗ |
| K855056 | EMDS TOTAL CK TEST PACK-#67670/95 | Em Diagnostic Systems, Inc. | 1986-01-22 | Traditional | PDF ↗ |
| K854501 | CK(OPTIMIZED) REAGENT | Sigma Diagnostics, Inc. | 1985-12-04 | Traditional | PDF ↗ |
| K852392 | EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE | Helena Laboratories | 1985-10-22 | Traditional | PDF ↗ |
| K852483 | SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 | Em Diagnostic Systems, Inc. | 1985-07-12 | Traditional | PDF ↗ |
| K852000 | CK-NAC REAGENT | Alpkem Corp. | 1985-05-30 | Traditional | PDF ↗ |
| K850212 | ISOENZYME TEST CK-MB | Sclavo, Inc. | 1985-02-07 | Traditional | PDF ↗ |
| K842755 | TITAN GEL ISO DOT CPK PROCEDURE | Helena Laboratories | 1984-09-28 | Traditional | PDF ↗ |
| K843271 | SYSTEMATE CK-TOTAL - 67206 | Em Diagnostic Systems, Inc. | 1984-09-07 | Traditional | PDF ↗ |
| K842508 | CREATINE KINASE ASSAY KIT NAC | Diagnostic Chemicals, Ltd. (Usa) | 1984-07-20 | Traditional | PDF ↗ |
| K842013 | SIGMA PROCEDURE 47-UV | Sigma Chemical Co. | 1984-06-25 | Traditional | PDF ↗ |
| K840783 | CREATINE KINASE MB REAGENT | American Dade | 1984-04-04 | Traditional | PDF ↗ |
| K834502 | CK-NAC REAGENT | Roche Diagnostic Systems, Inc. | 1984-02-27 | Traditional | PDF ↗ |
| K833781 | DURAZYME CPK | American Monitor Corp. | 1984-01-18 | Traditional | PDF ↗ |
| K831965 | CREATINE KINASE REAGENT CK LTS | Electro-Nucleonics Laboratories, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K831537 | PARAMAX CREATINE KINASE REAGENT | American Dade | 1983-06-22 | Traditional | PDF ↗ |
| K821883 | ULTRAZYME PLUS CK-I | Harleco Diagnostics | 1982-07-14 | Traditional | PDF ↗ |
| K821473 | ULTRAZYME PLUS CKI, #64978,65027&65028 | Emd Chemicals, Inc. | 1982-06-03 | Traditional | PDF ↗ |
| K821464 | CARDIOZYME PLUS CK-MB, #65045 | Emd Chemicals, Inc. | 1982-06-02 | Traditional | PDF ↗ |
| K821460 | ULTRAZYME PLUS CK-I, #64978,65027&65028 | Emd Chemicals, Inc. | 1982-06-01 | Traditional | PDF ↗ |
| K821240 | LIQUID-STAT LIQUID ENZYME REAGENT | Beckman Instruments, Inc. | 1982-05-21 | Traditional | PDF ↗ |
| K820880 | SERALYZER CK REAGENT STRIPS | Miles Laboratories, Inc. | 1982-04-16 | Traditional | PDF ↗ |
Product code CGS · Class II · Clinical Chemistry. Data: openFDA.