Atlas FDA

JHS

38 FDA 510(k) clearances · Product code

39 daysmedian time to decision
74 days90th percentile
38clearances measured

FDA profile

Official device name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1215
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2003: 2 · 2008: 5 · 2009: 11 · 2010: 26 · 2011: 18 · 2020: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Creatine Kinase (K160570)Roche Diagnostics Operations (Rdo)2016-05-25
CKMB UDR ASSAY (K102706)SENTINEL CH. SpA2011-08-19
S40 CREATINE KINASE (CK) (K082226)Alfa Wassermann Diagnostic Technologies, Inc.2008-09-18
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS (K062128)Dade Behring, Inc.2006-08-21
CARESIDE CK (K990439)Careside, Inc.1999-04-19
CARESIDE CKMB (K990434)Careside, Inc.1999-04-19
IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) (K981495)Diagnostic Products Corp.1998-06-10
ACS CKMB II IMMUNOASSAY (K962126)Ciba Corning Diagnostics Corp.1996-06-21
STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT (K952250)Dade Intl., Inc.1995-07-17
ACCESS CK-MB REAGENTS (K945083)Bio-Rad Laboratories, Inc.1994-11-21
KINASE ISOENZYME (K943024)Dupont Medical Products1994-08-02
CREATINE KINASE METHOD (K941584)Dupont Medical Products1994-07-06
ROCHE ISOMUNE- CK (K903025)Roche Diagnostic Systems, Inc.1990-08-09
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (K900806)Baxter Healthcare Corp1990-03-23
CHECK-MM (K883223)Intl. Immunoassay Laboratories, Inc.1988-09-30
UNI-FAST CREATINE KINASE TEST (CK) (K872029)Sclavo, Inc.1987-06-17
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB) (K861387)Eastman Kodak Company1986-06-27
CPK (UV) REAGENT KIT (K855188)Technostics Intl.1986-03-05
DART CK-MB REAGENT SYSTEM (K854708)Coulter Electronics, Inc.1985-12-30
CARDI-CK EIA TEST KIT CK-MB ISOENZYME (K843007)Intl. Immunoassay Laboratories, Inc.1984-09-07
CK-UV REAGENT (K823211)Biorent Diagnostic, Inc.1982-11-22
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE (K820722)Eastman Kodak Company1982-04-01
CPK(CK) IN VITRO DIAG. REAGENT SET (K813406)Pointe Scientific, Inc.,1981-12-22
WORTHINGTON CK (NAC) REAGENT SET (K810997)Worthington Diagnostic Systems1981-04-23
CARDIOZYME PLUS CK-TOTAL #65046 (K803169)Harleco1981-01-09
CK-MB(IMMUNOLOGICAL) (K802521)Biodynamics Corp.1980-11-12
QUICK CEPT (K801668)Laboratory Diagnostics Co., Inc.1980-08-13
WORTHINGTON FLOZYME* CPK (340NM) (K800028)Worthington Diagnostic Systems1980-01-21
ESKACHEM, CK-MB REAGENT (K792023)Smithkline Diagnostics, Inc.1979-10-30
SPIN CHEM CK-NAC REAGENT (K790917)Smithkline Diagnostics, Inc.1979-06-22
ESKLAB REAGENT TABLETS (K790918)Smithkline Diagnostics, Inc.1979-06-22
CK-NUC REAGENT (K790916)Smithkline Diagnostics, Inc.1979-06-22
DATA-ZYME CK CALORIMETRIC/UV PROCEDURE (K790343)Data Medical Associates, Inc.1979-05-01
ACA CREATINE KINASE ISOENZYMES (K790088)E.I. Dupont DE Nemours & Co., Inc.1979-03-12
SERUM, CREATININE PHOSPHOKINASE (K790015)Fisher Scientific Co., LLC1979-02-15
L-CYSTEINE HYDROCHLORIDE (K781690)Fisher Scientific Co., LLC1978-10-27
STAT ULTRA VIOLET LIQUID (K781432)Beckman Instruments, Inc.1978-10-03
CREATINE PHOSPHOKINASE (CPK) (K780504)Gamma Enterprises, Inc.1978-05-03

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Every clearance here is in the API, with alerts when new ones post.