Panels › Clinical Chemistry › Product code CGS · Class 2
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Regulation 862.1215
0510(k)s in 12 months (123 all time)
1recalls in 12 months (10 all time)
8recalls that name a 510(k)
Top companies in CGS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 23, 1990 | K901267 | COULTER CK (CREATINE KINASE) REAGENT Coulter Corp. | CGS |
| Nov 8, 1989 | K894715 | CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS Catachem, Inc. | CGS |
| Aug 31, 1989 | K893691 | EMDS CREATINE KINASE ITEM NIMBER 65411 Diagnostic Systems | CGS |
| Jul 20, 1989 | K893269 | BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME Beckman Instruments, Inc. | CGS |
| Jul 20, 1989 | K893007 | REP(TM) CK-2 STAT KIT, CAT. NO. 3074 Helena Laboratories | CGS |
| May 22, 1989 | K891462 | ROCHE(R) CARDIOSCREEN-CK Roche Diagnostic Systems, Inc. | CGS |
| May 9, 1989 | K891470 | CK-NAC 2-VIAL REAGENT W/SUBSTRATE START Trace Scientific , Ltd., AU | CGS |
| Mar 16, 1989 | K890609 | IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) Intl. Immunoassay Laboratories, Inc. | CGS |
| Feb 27, 1989 | K890540 | ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC Abbott Laboratories | CGS |
| Feb 10, 1989 | K884547 | CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673 Em Diagnostic Systems, Inc. | CGS |
| Feb 2, 1989 | K884546 | CREATINE KINASE TEST (CK) ITEM NUMBER: 65661 Em Diagnostic Systems, Inc. | CGS |
| Oct 13, 1988 | K883946 | VISION CREATINE KINASE Abbott Laboratories | CGS |
| Sep 13, 1988 | K883504 | DURAZYME(R) CPK American Monitor Corp. | CGS |
| Nov 5, 1987 | K874146 | TITAN GEL REP CPK-12 HV Helena Laboratories | CGS |
| Nov 5, 1987 | K873201 | WAKO(TM) AUTOKIT CK-NAC Wako Chemicals USA, Inc. | CGS |
| Nov 3, 1987 | K874140 | TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED. Helena Laboratories | CGS |
| Nov 3, 1987 | K874139 | TITAN GEL REP CPK-30 HV Helena Laboratories | CGS |
| Sep 16, 1987 | K873134 | UNIFAST CK-MB Sclavo, Inc. | CGS |
| Mar 10, 1987 | K870462 | EASY-TEST CREATINE KINASE-MB (CK-MB) #16615 Em Diagnostic Systems, Inc. | CGS |
| Mar 6, 1987 | K870461 | EASY-TEST CREATINE KINASE (CK) NUMBER: 16614 Em Diagnostic Systems, Inc. | CGS |
| Feb 6, 1987 | K864359 | CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) Trace Scientific , Ltd., AU | CGS |
| Jan 13, 1987 | K864744 | CREATINE PHOSPHOKINASE (CK) Tech-Co, Inc. | CGS |
| Oct 3, 1986 | K863587 | CREATINE PHOSPHOKINASE(CK) PROCEDURE Data Medical Associates, Inc. | CGS |
| Jun 5, 1986 | K861665 | CREATINE PHROSPHOKINASE (CK) PROCEDURE Data Medical Associates, Inc. | CGS |
| May 29, 1986 | K861879 | CK REAGENT CARTRIDGE (PRODUCT NO. 88213) Hi Chem, Inc. | CGS |
| Apr 24, 1986 | K861061 | EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK Em Diagnostic Systems, Inc. | CGS |
| Apr 24, 1986 | K860733 | CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE Trace Scientific , Ltd., AU | CGS |
| Apr 7, 1986 | K860669 | CREATINE KINASE, N-ACETYL-L-CYSTIENE Em Diagnostic Systems, Inc. | CGS |
| Feb 11, 1986 | K860096 | CPK REAGENT SET (COLORIMETRIC) Sterling Diagnostics, Inc. | CGS |
| Jan 22, 1986 | K855056 | EMDS TOTAL CK TEST PACK-#67670/95 Em Diagnostic Systems, Inc. | CGS |
| Dec 4, 1985 | K854501 | CK(OPTIMIZED) REAGENT Sigma Diagnostics, Inc. | CGS |
| Oct 22, 1985 | K852392 | EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE Helena Laboratories | CGS |
| Jul 12, 1985 | K852483 | SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 Em Diagnostic Systems, Inc. | CGS |
| May 30, 1985 | K852000 | CK-NAC REAGENT Alpkem Corp. | CGS |
| Feb 7, 1985 | K850212 | ISOENZYME TEST CK-MB Sclavo, Inc. | CGS |
| Sep 28, 1984 | K842755 | TITAN GEL ISO DOT CPK PROCEDURE Helena Laboratories | CGS |
| Sep 7, 1984 | K843271 | SYSTEMATE CK-TOTAL - 67206 Em Diagnostic Systems, Inc. | CGS |
| Jul 20, 1984 | K842508 | CREATINE KINASE ASSAY KIT NAC Diagnostic Chemicals, Ltd. (Usa) | CGS |
| Jun 25, 1984 | K842013 | SIGMA PROCEDURE 47-UV Sigma Chemical Co. | CGS |
| Apr 4, 1984 | K840783 | CREATINE KINASE MB REAGENT American Dade | CGS |
| Feb 27, 1984 | K834502 | CK-NAC REAGENT Roche Diagnostic Systems, Inc. | CGS |
| Jan 18, 1984 | K833781 | DURAZYME CPK American Monitor Corp. | CGS |
| Sep 12, 1983 | K831965 | CREATINE KINASE REAGENT CK LTS Electro-Nucleonics Laboratories, Inc. | CGS |
| Jun 22, 1983 | K831537 | PARAMAX CREATINE KINASE REAGENT American Dade | CGS |
| Jul 14, 1982 | K821883 | ULTRAZYME PLUS CK-I Harleco Diagnostics | CGS |
| Jun 3, 1982 | K821473 | ULTRAZYME PLUS CKI, #64978,65027&65028 Emd Chemicals, Inc. | CGS |
| Jun 2, 1982 | K821464 | CARDIOZYME PLUS CK-MB, #65045 Emd Chemicals, Inc. | CGS |
| Jun 1, 1982 | K821460 | ULTRAZYME PLUS CK-I, #64978,65027&65028 Emd Chemicals, Inc. | CGS |
| May 21, 1982 | K821240 | LIQUID-STAT LIQUID ENZYME REAGENT Beckman Instruments, Inc. | CGS |
| Apr 16, 1982 | K820880 | SERALYZER CK REAGENT STRIPS Miles Laboratories, Inc. | CGS |
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