Atlas FDA

JHY

40 FDA 510(k) clearances · Product code

50 daysmedian time to decision
208 days90th percentile
40clearances measured

FDA profile

Official device name
Colorimetric 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)
1998: 2 · 1999: 1 · 2001: 2 · 2003: 2 · 2004: 5 · 2017: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Dimension Vista MMB Assay (K143720)Siemens Healthcare Diagnostics2015-09-18
EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL (K130080)Medica Corporation2014-05-13
ELECSYS CK-MB STAT IMMUNOASSAY (K140404)Roche Diagnostics2014-05-08
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY (K132571)Roche Diagnostics2013-10-18
OLYMPUS CK-MB REAGENT (K070835)Olympus Life & Material Science Europa GmbH (Irish2007-06-04
SPIFE CK KIT, MODEL 3332, 3333 (K022757)Helena Laboratories2002-10-11
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB (K022654)Roche Diagnostics Corp.2002-08-29
ELECSYS CK-MB STAT (K974421)Boehringer Mannheim Corp.1997-12-17
MMB METHOD (K970343)Dade Chemistry Systems, Inc.1997-02-14
CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO (K961412)Bayer Corp.1996-06-18
AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK (K951638)Organon Teknika Corp.1995-05-02
IMX(R) STAT CK-MB (K931172)Abbott Laboratories1993-06-15
OPUS(R) CK-MB (K924429)Pb Diagnostic Systems, Inc.1992-10-15
DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. (K922700)E.I. Dupont DE Nemours & Co., Inc.1992-08-20
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY (K921763)Hybritech, Inc.1992-06-09
AMERLITE CK-MB ASSAY (K912766)Amersham Corp.1991-07-17
COBAS READY CK REAGENT (K896240)Roche Diagnostic Systems, Inc.1990-02-16
ISOSCREEN-CK CONFIRMATORY KIT (K895870)Roche Diagnostic Systems, Inc.1989-12-01
TARGET(TM) CK-MB (K890295)V-Tech, Inc.1989-08-15
CREATINE KINASE MB ENZYME IMMUNOASSAY KIT (K884550)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-02-23
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY (K884085)Hybritech, Inc.1988-12-02
IMX CKMB (K883013)Abbott Laboratories1988-08-08
IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225 (K881351)Intl. Immunoassay Laboratories, Inc.1988-06-01
KODAK EKTACHEM DT SLIDES (CKMB) (K875192)Eastman Kodak Company1988-02-24
CREATINE KINASE (COLORIMETRIC METHOD) (K880178)Tech-Co, Inc.1988-02-18
IMACK-MB TEST PROCEDURE (MODIFICATION) (K874545)Intl. Immunoassay Laboratories, Inc.1987-12-18
TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II (K872063)Hybritech, Inc.1987-06-19
CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS (K871677)Catachem, Inc.1987-05-12
AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT (K860663)Amresco, Inc.1986-04-11
BAKER CKMB REAGENT SET (K845024)Hybritech, Inc.1985-01-18
FLOW-PAC CPK REAGENT SET (K832977)American Research Products Co.1984-04-05
TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY (K832139)Hybritech, Inc.1983-08-12
WAKO CPK TEST (K832004)Wako Chemicals USA, Inc.1983-08-11
CREATINE KINASE REAGENT SET (K830672)Sterling Biochemical, Inc.1983-04-05
CREATINE KINASE-MB KIT (K820812)Calbiochem-Behring Corp.1982-04-12
REAGENT FOR DETERM. CREATINE PHOSPHOKINA (K800684)Diagnostic Solutions, Inc.1980-05-28
CPK ISOENZYME REAGENT (K791655)Electrophoresis Corp. of America1979-09-17
CPK ISOENZYME SUBSTRATE (K790309)Electrophoresis Corp.1979-04-04
CPK1SOENZYMES DETERMINATION PRO. #715-EP (K761212)Sigma Chemical Co.1976-12-21
LANCER MB/CPK ISOENZYME KIT (K760871)Sherwood Medical Industries1976-11-02

Track JHY automatically

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