Panels › Clinical Chemistry › Product code JHT · Class 2
Chromatographic Separation, Cpk Isoenzymes
Regulation 862.1215
0510(k)s in 12 months (21 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in JHT
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 2002 | K022409 | SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST Spectral Diagnostics, Inc., CA | JHT |
| May 28, 1999 | K991299 | MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI Princeton BioMeditech Corp. | JHT |
| Apr 12, 1993 | K930359 | CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 Helena Laboratories | JHT |
| Dec 13, 1990 | K904866 | COULTER CK-MB ISOENZYME REAGENT Coulter Electronics, Inc. | JHT |
| Dec 13, 1990 | K904721 | DSL CK-MB (DSL #3200) Diagnostic Systems Laboratories, Inc. | JHT |
| May 15, 1990 | K901450 | MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB Intl. Immunoassay Laboratories, Inc. | JHT |
| Feb 16, 1990 | K896170 | REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 Helena Laboratories | JHT |
| Nov 10, 1988 | K881168 | CREATINE KINASE (CK) ISOENZYME MB Data Medical Associates, Inc. | JHT |
| Jan 21, 1988 | K874284 | SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM Diagnostic Chemicals, Ltd. (Usa) | JHT |
| Sep 16, 1987 | K872041 | COULTER DART CK-MB ISOENZYME REAGENT SYSTEM Coulter Electronics, Inc. | JHT |
| Aug 3, 1987 | K872598 | MICROMI-CK(TM) Intl. Immunoassay Laboratories, Inc. | JHT |
| Jul 31, 1987 | K872592 | IMACK-MB(TM) Intl. Immunoassay Laboratories, Inc. | JHT |
| Nov 4, 1983 | K831391 | SHOT GUN KIT FOR CK-MB Serapine Corp. | JHT |
| Jan 7, 1983 | K823550 | CK-ISOZYME U.V. REAGENT SET Gelman Sciences, Inc. | JHT |
| Nov 1, 1982 | K822124 | TITAN GEL CPK ISOENZYME SYSTEM Helena Laboratories | JHT |
| Jul 22, 1982 | K821964 | 125I QUICK-MB TEST KIT FOR QUANTITATION Intl. Immunoassay Laboratories, Inc. | JHT |
| Mar 11, 1981 | K810534 | GEMENI QUICK-MB SEPARATION KIT Gemini, Inc. | JHT |
| Oct 1, 1979 | K791826 | CPK CLINI GEL KIT Clinical Sciences, Inc. | JHT |
| Apr 4, 1979 | K790357 | CPK-CS Hoffmann-La Roche, Inc. | JHT |
| Aug 22, 1977 | K771497 | CK-MB Boehringer Mannheim Corp. | JHT |
| Sep 15, 1976 | K760028 | CPK - ISOENZYMES Harleco | JHT |
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