Atlas FDA

CGS

123 FDA 510(k) clearances · Product code

42 daysmedian time to decision
107 days90th percentile
123clearances measured

FDA profile

Official device name
Nad Reduction/Nadh Oxidation, 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)
2007: 64 · 2018: 1,434
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
Pointe Scientific Creatinine Kinase (CK) Reagent Set (K191296)Medtest DX2020-08-11
SEKURE Creatine Kinase Assay (K182702)Sekisui Diagnostics P.E.I., Inc.2019-04-17
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator (K160724)Siemens Healthcare Diagnostics, Inc.2016-09-07
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR (K123977)Randox Laboratories, Ltd.2013-11-21
CPK REAGENT (K112416)Vital Diagnostics (Manufacturing) Ptyltd2011-11-09
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE (K083465)Siemens Healthcare Diagnostics2009-02-27
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 (K081731)Siemens Healthcare Diagnostics2008-08-29
CREATINE KINASE LIQUID REAGENT, MODEL C519-440 (K072548)Teco Diagnostics2008-04-18
CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (K062737)Horiba Abx2007-06-12
SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS (K051648)Arkray, Inc.2006-01-31
OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 (K043202)Olympus America, Inc.2004-12-23
WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA (K021332)Wiener Laboratories Saic2002-07-03
CREATINE KINASE (CK-NAC) (K013912)Jas Diagnostics, Inc.2002-01-18
ATAC PAK CPK REAGENT KIT (K012474)Elan Holdings, Inc.2001-10-03
OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 (K994189)Olympus Diagnostica GmbH2000-01-20
HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT (K992148)Morax1999-12-29
CK (K983070)Abbott Laboratories1999-02-16
CREATINE KINASE (CK) (K981218)Abbott Laboratories1998-05-01
N-ASSAY CPK-L (K980900)Crestat Diagnostics, Inc.1998-03-26
CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 (K973999)Diagnostic Chemicals , Ltd.1998-03-11
CK-NAC REAGENT (K974833)Intersect Systems, Inc.1998-02-13
CREATINE KINASE (CK) (K972155)Stanbio Laboratory1997-07-17
CREATINE KINASE-MB REAGENT SET (K971566)Horizon Diagnostics, Inc.1997-07-14
CK REAGENT (K971396)Carolina Liquid Chemistries Corp.1997-05-29
HICHEM CK/NAC REAGENT KIT (K962247)Elan Pharma, Inc.1996-08-15
CK-MB (NAC-ACT) (K951223)Randox Laboratories, Ltd.1995-12-26
CREATINE KINASE REAGENT SYSTEM (K952745)Medical Diagnostic Technologies, Inc.1995-08-11
IL TEST CK-MB (K952646)Instrumentation Laboratory CO1995-08-04
CK QVET (K950177)Prisma Systems1995-03-03
CK-MB ASSAY, CATALOGUE NUMBER 317-10 (K942773)Diagnostic Chemicals , Ltd.1994-08-24
CREATINE KINASE-MB (CK-MB) REAGENT SET (K935463)Pointe Scientific, Inc.,1994-01-11
OPUS TOTAL CK (K933675)Pb Diagnostic Systems, Inc.1993-09-08
CREATINE KINASE TEST (K931889)Em Diagnostic Systems, Inc.1993-07-27
KING DIAGNOSTICS CK REAGENT (K931326)King Diagnostics, Inc.1993-06-15
SYNERMED CREATINE KINASE REAGENT KIT (K930932)Synermed, Inc.1993-05-11
CREATINE KINASE (CK) REAGENT SET (K930660)Pointe Scientific, Inc.,1993-03-29
OLYMPUS CREATINE KINASE REAGENT (K924832)Olympus Corp.1993-01-04
REP E-Z CK-30 ISOENZYME KIT (K925801)Helena Laboratories1992-12-28
CK-NAC ACTIVATED KIT (K923511)Randox Laboratories, Ltd.1992-10-15
CREATINE KINASE (CK) TEST ITEM #65411 (K924704)Em Diagnostic Systems, Inc.1992-10-13
OLYMPUS CREATINE KINASE REAGENT (K922459)Olympus Corp.1992-07-13
CREATINE KINASE-MB (CK-MB) REAGENT SET (K915709)Tech Intl. Co.1992-01-27
CREATINE KINASE MB TEST ITEM NUMBER 5A46 (K914361)Em Diagnostic Systems, Inc.1991-12-13
RAICHEM(TM) CREATINE KINASE-MB REAGENT (K913398)Reagents Applications, Inc.1991-09-25
RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV (K905084)Reagents Applications, Inc.1990-12-20
AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116 (K904004)Amresco, Inc.1990-12-11
CREATINE PHOSPHOKINASE (K903775)Amresco, Inc.1990-10-04
REFLOTRON CREATINE KINASE TEST TABS (K904102)Boehringer Mannheim Corp.1990-09-27
CREATINE KINASE TEST (CK) ITEM NUMBER 65411 (K903333)Em Diagnostic Systems, Inc.1990-08-17
CREATINE KINASE-MB TEST (MB-DS) ITEM #67655 (K902483)Em Diagnostic Systems, Inc.1990-07-10
COULTER CK (CREATINE KINASE) REAGENT (K901267)Coulter Corp.1990-05-23
CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS (K894715)Catachem, Inc.1989-11-08
EMDS CREATINE KINASE ITEM NIMBER 65411 (K893691)Diagnostic Systems1989-08-31
REP(TM) CK-2 STAT KIT, CAT. NO. 3074 (K893007)Helena Laboratories1989-07-20
BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME (K893269)Beckman Instruments, Inc.1989-07-20
ROCHE(R) CARDIOSCREEN-CK (K891462)Roche Diagnostic Systems, Inc.1989-05-22
CK-NAC 2-VIAL REAGENT W/SUBSTRATE START (K891470)Trace Scientific , Ltd.1989-05-09
IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) (K890609)Intl. Immunoassay Laboratories, Inc.1989-03-16
ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC (K890540)Abbott Laboratories1989-02-27
CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673 (K884547)Em Diagnostic Systems, Inc.1989-02-10
CREATINE KINASE TEST (CK) ITEM NUMBER: 65661 (K884546)Em Diagnostic Systems, Inc.1989-02-02
VISION CREATINE KINASE (K883946)Abbott Laboratories1988-10-13
DURAZYME(R) CPK (K883504)American Monitor Corp.1988-09-13
WAKO(TM) AUTOKIT CK-NAC (K873201)Wako Chemicals USA, Inc.1987-11-05
TITAN GEL REP CPK-12 HV (K874146)Helena Laboratories1987-11-05
TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED. (K874140)Helena Laboratories1987-11-03
TITAN GEL REP CPK-30 HV (K874139)Helena Laboratories1987-11-03
UNIFAST CK-MB (K873134)Sclavo, Inc.1987-09-16
EASY-TEST CREATINE KINASE-MB (CK-MB) #16615 (K870462)Em Diagnostic Systems, Inc.1987-03-10
EASY-TEST CREATINE KINASE (CK) NUMBER: 16614 (K870461)Em Diagnostic Systems, Inc.1987-03-06
CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) (K864359)Trace Scientific , Ltd.1987-02-06
CREATINE PHOSPHOKINASE (CK) (K864744)Tech-Co, Inc.1987-01-13
CREATINE PHOSPHOKINASE(CK) PROCEDURE (K863587)Data Medical Associates, Inc.1986-10-03
CREATINE PHROSPHOKINASE (CK) PROCEDURE (K861665)Data Medical Associates, Inc.1986-06-05
CK REAGENT CARTRIDGE (PRODUCT NO. 88213) (K861879)Hi Chem, Inc.1986-05-29
EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK (K861061)Em Diagnostic Systems, Inc.1986-04-24
CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE (K860733)Trace Scientific , Ltd.1986-04-24
CREATINE KINASE, N-ACETYL-L-CYSTIENE (K860669)Em Diagnostic Systems, Inc.1986-04-07
CPK REAGENT SET (COLORIMETRIC) (K860096)Sterling Diagnostics, Inc.1986-02-11
EMDS TOTAL CK TEST PACK-#67670/95 (K855056)Em Diagnostic Systems, Inc.1986-01-22
CK(OPTIMIZED) REAGENT (K854501)Sigma Diagnostics, Inc.1985-12-04
EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE (K852392)Helena Laboratories1985-10-22
SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 (K852483)Em Diagnostic Systems, Inc.1985-07-12
CK-NAC REAGENT (K852000)Alpkem Corp.1985-05-30
ISOENZYME TEST CK-MB (K850212)Sclavo, Inc.1985-02-07
TITAN GEL ISO DOT CPK PROCEDURE (K842755)Helena Laboratories1984-09-28
SYSTEMATE CK-TOTAL - 67206 (K843271)Em Diagnostic Systems, Inc.1984-09-07
CREATINE KINASE ASSAY KIT NAC (K842508)Diagnostic Chemicals, Ltd. (Usa)1984-07-20
SIGMA PROCEDURE 47-UV (K842013)Sigma Chemical Co.1984-06-25
CREATINE KINASE MB REAGENT (K840783)American Dade1984-04-04
CK-NAC REAGENT (K834502)Roche Diagnostic Systems, Inc.1984-02-27
DURAZYME CPK (K833781)American Monitor Corp.1984-01-18
CREATINE KINASE REAGENT CK LTS (K831965)Electro-Nucleonics Laboratories, Inc.1983-09-12
PARAMAX CREATINE KINASE REAGENT (K831537)American Dade1983-06-22
ULTRAZYME PLUS CK-I (K821883)Harleco Diagnostics1982-07-14
ULTRAZYME PLUS CKI, #64978,65027&65028 (K821473)Emd Chemicals, Inc.1982-06-03
CARDIOZYME PLUS CK-MB, #65045 (K821464)Emd Chemicals, Inc.1982-06-02
ULTRAZYME PLUS CK-I, #64978,65027&65028 (K821460)Emd Chemicals, Inc.1982-06-01
LIQUID-STAT LIQUID ENZYME REAGENT (K821240)Beckman Instruments, Inc.1982-05-21
SERALYZER CK REAGENT STRIPS (K820880)Miles Laboratories, Inc.1982-04-16
Next →

Track CGS automatically

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