Atlas FDA

JHT

21 FDA 510(k) clearances · Product code

52 daysmedian time to decision
114 days90th percentile
21clearances measured

FDA profile

Official device name
Chromatographic Separation, Cpk Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1215
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST (K022409)Spectral Diagnostics, Inc.2002-09-30
MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI (K991299)Princeton BioMeditech Corp.1999-05-28
CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 (K930359)Helena Laboratories1993-04-12
COULTER CK-MB ISOENZYME REAGENT (K904866)Coulter Electronics, Inc.1990-12-13
DSL CK-MB (DSL #3200) (K904721)Diagnostic Systems Laboratories, Inc.1990-12-13
MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB (K901450)Intl. Immunoassay Laboratories, Inc.1990-05-15
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 (K896170)Helena Laboratories1990-02-16
CREATINE KINASE (CK) ISOENZYME MB (K881168)Data Medical Associates, Inc.1988-11-10
SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM (K874284)Diagnostic Chemicals, Ltd. (Usa)1988-01-21
COULTER DART CK-MB ISOENZYME REAGENT SYSTEM (K872041)Coulter Electronics, Inc.1987-09-16
MICROMI-CK(TM) (K872598)Intl. Immunoassay Laboratories, Inc.1987-08-03
IMACK-MB(TM) (K872592)Intl. Immunoassay Laboratories, Inc.1987-07-31
SHOT GUN KIT FOR CK-MB (K831391)Serapine Corp.1983-11-04
CK-ISOZYME U.V. REAGENT SET (K823550)Gelman Sciences, Inc.1983-01-07
TITAN GEL CPK ISOENZYME SYSTEM (K822124)Helena Laboratories1982-11-01
125I QUICK-MB TEST KIT FOR QUANTITATION (K821964)Intl. Immunoassay Laboratories, Inc.1982-07-22
GEMENI QUICK-MB SEPARATION KIT (K810534)Gemini, Inc.1981-03-11
CPK CLINI GEL KIT (K791826)Clinical Sciences, Inc.1979-10-01
CPK-CS (K790357)Hoffmann-La Roche, Inc.1979-04-04
CK-MB (K771497)Boehringer Mannheim Corp.1977-08-22
CPK - ISOENZYMES (K760028)Harleco1976-09-15

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