Atlas FDA

JHW

27 FDA 510(k) clearances · Product code

50 daysmedian time to decision
173 days90th percentile
27clearances measured

FDA profile

Official device name
U.V. Method, Cpk Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1215
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2005: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Creatine Kinase-MB (K162526)Roche Diagnostics2017-05-26
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT (K141265)Elitechgroup2014-07-18
ELITECH CLINICAL SYSTEMS CK NAC SL (K122083)Elitechgroup2012-08-22
WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 (K023744)Wiener Laboratories Saic2003-01-03
ROCHE DIAGNOSTICS CK-MB (K003158)Roche Diagnostics Corp.2000-12-18
ELECSYS CK-MB (K961501)Boehringer Mannheim Corp.1996-06-11
CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (K950186)Miles, Inc.1995-03-13
LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN (K944325)Princeton BioMeditech Corp.1995-02-22
CREATINE KINASE MB DETERMINATION (UV) (K942958)Biochemical Trade, Inc.1994-11-21
AXSYM CK-MB (K935924)Abbott Laboratories1994-06-21
CARDIO REP CK ISOENZYME KIT - 3310 (K931050)Helena Laboratories1993-04-20
STAMBI-CK (K913349)Intl. Immunoassay Laboratories, Inc.1991-10-23
PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT (K912231)Intl. Immunoassay Laboratories, Inc.1991-07-08
CREATINE KINASE UV REAGENT SET (K905588)Biochemical Trade, Inc.1991-01-17
LABELLING CHANGES TO IMPRES-MB-X (K903508)Intl. Immunoassay Laboratories, Inc.1990-09-07
ISOFOR-MM (TM) (K883222)Intl. Immunoassay Laboratories, Inc.1988-09-30
IMPRES-MB (K881801)Intl. Immunoassay Laboratories, Inc.1988-06-08
DSL 1700 (K822897)Diagnostic Systems Laboratories, Inc.1982-12-15
CARDIOZYME PLUS CK-MB ITEM #65045 (K811573)Harleco1981-06-25
CARDIOZYME PLUS CK-MB ITEM #65045 (G) (K811575)Harleco1981-06-25
CREATINE KINASE MB ISOENZYME IMMUNO UV (K810861)The Dow Chemical Co.1981-04-14
ISOMUNE-CK (K810905)Hoffmann-La Roche, Inc.1981-04-14
CARDIO ZYME PLUS CK-MB #65045 (K803168)Harleco1981-01-09
CREATINE PHOSPHOKINASE (CPK) REAGENT SET (K792533)Macomb Chemical Co.1980-01-11
A-GENT CK-MB (K782015)Abbott Laboratories1979-02-01
CPK ISOENZYME REAGENT (K781124)Electrophoresis Corp. of America1978-08-10
DYNAZYME TM II CARDIAK-MB (K772172)J.T. Baker Chemical Co.1977-12-06

Track JHW automatically

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