Atlas FDA

JQB

52 FDA 510(k) clearances · Product code

36 daysmedian time to decision
133 days90th percentile
52clearances measured

FDA profile

Official device name
Kinetic Method, Gamma-Glutamyl Transpeptidase
Device class
Class I (low risk)
Regulation
21 CFR 862.1360
Medical specialty
Clinical Chemistry
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RecordFirmDate
Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 (K974000)Diagnostic Chemicals , Ltd.1997-11-04
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET (K973157)Pointe Scientific, Inc.,1997-10-10
SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) (K971466)Carolina Liquid Chemistries Corp.1997-05-06
ROCHE COBAS IBTEGRA REAGENT CASSETTES (K964457)Roche Diagnostic Systems, Inc.1997-01-13
GAMMA-GLUTAMYL TRANSPEPTIDASE (K964916)Derma Media Lab., Inc.1997-01-10
GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM (K955770)Abaxis, Inc.1996-09-09
Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 (K945800)Diagnostic Chemicals , Ltd.1995-06-09
HICHEM Y-GT REAGENT KIT (K946192)Hichem Diagnostics1995-05-02
GGT QVET (K942962)Prisma Systems1994-12-07
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 (K935984)Sigma Diagnostics, Inc.1994-07-20
STANBIO Y-GT (LIQUICOLOR) TEST SET (K941315)Stanbio Laboratory1994-07-14
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (K935177)Em Diagnostic Systems, Inc.1993-12-16
SYNERMED GGT REAGENT KIT (K931958)Synermed, Inc.1993-09-08
OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT (K925337)Olympus Corp.1993-01-26
ROCHE REAGENT FOR GGT (K924246)Roche Diagnostic Systems, Inc.1992-11-18
GAMMA GULTAMYL TRANSFERASE TEST (K922947)Em Diagnostic Systems, Inc.1992-09-28
OLYMPUS GGT REAGENT (K922230)Olympus Corp.1992-06-25
TRACE GAMMA GT-SS REAGENT (K914731)Trace Scientific , Ltd.1991-11-19
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST (K913024)Em Diagnostic Systems, Inc.1991-07-26
GAMMA-GLUTAMYL TRANSFERASE DETERMINATION (K905649)Biochemical Trade, Inc.1991-01-30
SYSTEMATE GGT (EPOS APPLICATION) #65414 (K905662)Em Diagnostic Systems, Inc.1991-01-04
RAICHEM GGT REAGENT (K905085)Reagents Applications, Inc.1990-12-20
GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 (K905096)Amresco, Inc.1990-11-28
COULTER GAMMA-GT (GGT) REAGENT (K901264)Coulter Corp.1990-04-16
GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 (K893765)Em Diagnostic Systems, Inc.1989-07-20
GAMMA-GLUTAMYLTRANSFERASE (K890312)American Monitor Corp.1989-03-24
GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664 (K884988)Em Diagnostic Systems, Inc.1989-01-13
GAMMA-GLUTAMYL TRANSFERASE (K881626)Tech-Co, Inc.1988-05-27
BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (K881311)Biotrol, USA, Inc.1988-04-28
GAMMA GLUTAMYLTRANSFERASE (K873378)Catachem, Inc.1987-09-08
UNIFAST GAMMA-GT (K873135)Sclavo, Inc.1987-09-04
EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616 (K872320)Em Diagnostic Systems, Inc.1987-07-27
EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95 (K872322)Em Diagnostic Systems, Inc.1987-07-27
EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93 (K860640)Em Diagnostic Systems, Inc.1986-04-09
G-GT REAGENT (K851999)Alpkem Corp.1985-06-10
Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT (K850319)Sigma Diagnostics, Inc.1985-02-12
GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED (K844720)Data Medical Associates, Inc.1984-12-12
SYSTEMATE 2GT - 67207 (K843268)Em Diagnostic Systems, Inc.1984-09-13
DART GAMMA-GT REAGENT SYSTEM (K834054)Coulter Electronics, Inc.1984-02-04
FLOW-PAC GGT REAGENT SET (K833029)American Research Products Co.1983-12-29
PARAMAX & GLUTAMYTRANSFERASE REAGENT (K833001)American Dade1983-10-14
ULTRA ZYME PLUS GAMMA GT #65055 & 56 (K830308)Emd Chemicals, Inc.1983-02-28
ULTRAZYME PLUS GAMMA GT-MCA #65055-65056 (K830240)Emd Chemicals, Inc.1983-02-18
CAST SHOE, CAST BOOT (K830246)Warm & Form, Orthopedic Materials1983-02-18
ULTRAZYME PLUS GAMMA-GT, #64959/65032 (K823883)Emd Chemicals, Inc.1983-01-28
ULTRAZYME PLUS GAMMA GT(65055-65056) (K820233)Harleco1982-02-12
ULTRAZYME-GT, ITEM #64959 & 65032 (K813041)Harleco1981-11-10
GAMMA GLUTAMY TRANSPEPTIDASE (K812296)Pointe Scientific, Inc.,1981-08-31
GAMMA-GT REAGENT SYSTEM (K810434)American Monitor Corp.1981-02-26
Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST (K800769)Sclavo, Inc.1980-04-24
GAMA-GPT REAGENT SET (K780071)Medical Analysis Systems, Inc.1978-02-14
DIAGNOSTIC METHOD-8-GLUTAMYLTRANSFERASE (K761090)Technicon Instruments Corp.1976-12-02

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