Panels › Clinical Chemistry › Product code JHS · Class 2
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Regulation 862.1215
0510(k)s in 12 months (38 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
Top companies in JHS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 25, 2016 | K160570 | Creatine Kinase Roche Diagnostics Operations (Rdo) | JHS |
| Aug 19, 2011 | K102706 | CKMB UDR ASSAY SENTINEL CH. SpA, IT | JHS |
| Sep 18, 2008 | K082226 | S40 CREATINE KINASE (CK) Alfa Wassermann Diagnostic Technologies, Inc. | JHS |
| Aug 21, 2006 | K062128 | THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS Dade Behring, Inc. | JHS |
| Apr 19, 1999 | K990439 | CARESIDE CK Careside, Inc. | JHS |
| Apr 19, 1999 | K990434 | CARESIDE CKMB Careside, Inc. | JHS |
| Jun 10, 1998 | K981495 | IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) Diagnostic Products Corp. | JHS |
| Jun 21, 1996 | K962126 | ACS CKMB II IMMUNOASSAY Ciba Corning Diagnostics Corp. | JHS |
| Jul 17, 1995 | K952250 | STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT Dade Intl., Inc. | JHS |
| Nov 21, 1994 | K945083 | ACCESS CK-MB REAGENTS Bio-Rad Laboratories, Inc. | JHS |
| Aug 2, 1994 | K943024 | KINASE ISOENZYME Dupont Medical Products | JHS |
| Jul 6, 1994 | K941584 | CREATINE KINASE METHOD Dupont Medical Products | JHS |
| Aug 9, 1990 | K903025 | ROCHE ISOMUNE- CK Roche Diagnostic Systems, Inc. | JHS |
| Mar 23, 1990 | K900806 | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY Baxter Healthcare Corp | JHS |
| Sep 30, 1988 | K883223 | CHECK-MM Intl. Immunoassay Laboratories, Inc. | JHS |
| Jun 17, 1987 | K872029 | UNI-FAST CREATINE KINASE TEST (CK) Sclavo, Inc. | JHS |
| Jun 27, 1986 | K861387 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB) Eastman Kodak Company | JHS |
| Mar 5, 1986 | K855188 | CPK (UV) REAGENT KIT Technostics Intl. | JHS |
| Dec 30, 1985 | K854708 | DART CK-MB REAGENT SYSTEM Coulter Electronics, Inc. | JHS |
| Sep 7, 1984 | K843007 | CARDI-CK EIA TEST KIT CK-MB ISOENZYME Intl. Immunoassay Laboratories, Inc. | JHS |
| Nov 22, 1982 | K823211 | CK-UV REAGENT Biorent Diagnostic, Inc. | JHS |
| Apr 1, 1982 | K820722 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE Eastman Kodak Company | JHS |
| Dec 22, 1981 | K813406 | CPK(CK) IN VITRO DIAG. REAGENT SET Pointe Scientific, Inc., | JHS |
| Apr 23, 1981 | K810997 | WORTHINGTON CK (NAC) REAGENT SET Worthington Diagnostic Systems | JHS |
| Jan 9, 1981 | K803169 | CARDIOZYME PLUS CK-TOTAL #65046 Harleco | JHS |
| Nov 12, 1980 | K802521 | CK-MB(IMMUNOLOGICAL) Biodynamics Corp. | JHS |
| Aug 13, 1980 | K801668 | QUICK CEPT Laboratory Diagnostics Co., Inc. | JHS |
| Jan 21, 1980 | K800028 | WORTHINGTON FLOZYME* CPK (340NM) Worthington Diagnostic Systems | JHS |
| Oct 30, 1979 | K792023 | ESKACHEM, CK-MB REAGENT Smithkline Diagnostics, Inc. | JHS |
| Jun 22, 1979 | K790918 | ESKLAB REAGENT TABLETS Smithkline Diagnostics, Inc. | JHS |
| Jun 22, 1979 | K790917 | SPIN CHEM CK-NAC REAGENT Smithkline Diagnostics, Inc. | JHS |
| Jun 22, 1979 | K790916 | CK-NUC REAGENT Smithkline Diagnostics, Inc. | JHS |
| May 1, 1979 | K790343 | DATA-ZYME CK CALORIMETRIC/UV PROCEDURE Data Medical Associates, Inc. | JHS |
| Mar 12, 1979 | K790088 | ACA CREATINE KINASE ISOENZYMES E.I. Dupont DE Nemours & Co., Inc. | JHS |
| Feb 15, 1979 | K790015 | SERUM, CREATININE PHOSPHOKINASE Fisher Scientific Co., LLC | JHS |
| Oct 27, 1978 | K781690 | L-CYSTEINE HYDROCHLORIDE Fisher Scientific Co., LLC | JHS |
| Oct 3, 1978 | K781432 | STAT ULTRA VIOLET LIQUID Beckman Instruments, Inc. | JHS |
| May 3, 1978 | K780504 | CREATINE PHOSPHOKINASE (CPK) Gamma Enterprises, Inc. | JHS |
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