FDA Product Code
FDA Product Code JQB — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1360
510(k) Clearances — 52 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K974000 | Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 | Diagnostic Chemicals , Ltd. | 1997-11-04 | Traditional | PDF ↗ |
| K973157 | LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET | Pointe Scientific, Inc., | 1997-10-10 | Traditional | PDF ↗ |
| K971466 | SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) | Carolina Liquid Chemistries Corp. | 1997-05-06 | Traditional | PDF ↗ |
| K964457 | ROCHE COBAS IBTEGRA REAGENT CASSETTES | Roche Diagnostic Systems, Inc. | 1997-01-13 | Traditional | PDF ↗ |
| K964916 | GAMMA-GLUTAMYL TRANSPEPTIDASE | Derma Media Lab., Inc. | 1997-01-10 | Traditional | PDF ↗ |
| K955770 | GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM | Abaxis, Inc. | 1996-09-09 | Traditional | PDF ↗ |
| K945800 | Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 | Diagnostic Chemicals , Ltd. | 1995-06-09 | Traditional | PDF ↗ |
| K946192 | HICHEM Y-GT REAGENT KIT | Hichem Diagnostics | 1995-05-02 | Traditional | PDF ↗ |
| K942962 | GGT QVET | Prisma Systems | 1994-12-07 | Traditional | PDF ↗ |
| K935984 | GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 | Sigma Diagnostics, Inc. | 1994-07-20 | Traditional | PDF ↗ |
| K941315 | STANBIO Y-GT (LIQUICOLOR) TEST SET | Stanbio Laboratory | 1994-07-14 | Traditional | PDF ↗ |
| K935177 | GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | Em Diagnostic Systems, Inc. | 1993-12-16 | Traditional | PDF ↗ |
| K931958 | SYNERMED GGT REAGENT KIT | Synermed, Inc. | 1993-09-08 | Traditional | PDF ↗ |
| K925337 | OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT | Olympus Corp. | 1993-01-26 | Traditional | PDF ↗ |
| K924246 | ROCHE REAGENT FOR GGT | Roche Diagnostic Systems, Inc. | 1992-11-18 | Traditional | PDF ↗ |
| K922947 | GAMMA GULTAMYL TRANSFERASE TEST | Em Diagnostic Systems, Inc. | 1992-09-28 | Traditional | PDF ↗ |
| K922230 | OLYMPUS GGT REAGENT | Olympus Corp. | 1992-06-25 | Traditional | PDF ↗ |
| K914731 | TRACE GAMMA GT-SS REAGENT | Trace Scientific , Ltd. | 1991-11-19 | Traditional | PDF ↗ |
| K913024 | ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST | Em Diagnostic Systems, Inc. | 1991-07-26 | Traditional | PDF ↗ |
| K905649 | GAMMA-GLUTAMYL TRANSFERASE DETERMINATION | Biochemical Trade, Inc. | 1991-01-30 | Traditional | PDF ↗ |
| K905662 | SYSTEMATE GGT (EPOS APPLICATION) #65414 | Em Diagnostic Systems, Inc. | 1991-01-04 | Traditional | PDF ↗ |
| K905085 | RAICHEM GGT REAGENT | Reagents Applications, Inc. | 1990-12-20 | Traditional | PDF ↗ |
| K905096 | GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 | Amresco, Inc. | 1990-11-28 | Traditional | PDF ↗ |
| K901264 | COULTER GAMMA-GT (GGT) REAGENT | Coulter Corp. | 1990-04-16 | Traditional | PDF ↗ |
| K893765 | GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 | Em Diagnostic Systems, Inc. | 1989-07-20 | Traditional | PDF ↗ |
| K890312 | GAMMA-GLUTAMYLTRANSFERASE | American Monitor Corp. | 1989-03-24 | Traditional | PDF ↗ |
| K884988 | GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664 | Em Diagnostic Systems, Inc. | 1989-01-13 | Traditional | PDF ↗ |
| K881626 | GAMMA-GLUTAMYL TRANSFERASE | Tech-Co, Inc. | 1988-05-27 | Traditional | PDF ↗ |
| K881311 | BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | Biotrol, USA, Inc. | 1988-04-28 | Traditional | PDF ↗ |
| K873378 | GAMMA GLUTAMYLTRANSFERASE | Catachem, Inc. | 1987-09-08 | Traditional | PDF ↗ |
| K873135 | UNIFAST GAMMA-GT | Sclavo, Inc. | 1987-09-04 | Traditional | PDF ↗ |
| K872322 | EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95 | Em Diagnostic Systems, Inc. | 1987-07-27 | Traditional | PDF ↗ |
| K872320 | EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616 | Em Diagnostic Systems, Inc. | 1987-07-27 | Traditional | PDF ↗ |
| K860640 | EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93 | Em Diagnostic Systems, Inc. | 1986-04-09 | Traditional | PDF ↗ |
| K851999 | G-GT REAGENT | Alpkem Corp. | 1985-06-10 | Traditional | PDF ↗ |
| K850319 | Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT | Sigma Diagnostics, Inc. | 1985-02-12 | Traditional | PDF ↗ |
| K844720 | GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED | Data Medical Associates, Inc. | 1984-12-12 | Traditional | PDF ↗ |
| K843268 | SYSTEMATE 2GT - 67207 | Em Diagnostic Systems, Inc. | 1984-09-13 | Traditional | PDF ↗ |
| K834054 | DART GAMMA-GT REAGENT SYSTEM | Coulter Electronics, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K833029 | FLOW-PAC GGT REAGENT SET | American Research Products Co. | 1983-12-29 | Traditional | PDF ↗ |
| K833001 | PARAMAX & GLUTAMYTRANSFERASE REAGENT | American Dade | 1983-10-14 | Traditional | PDF ↗ |
| K830308 | ULTRA ZYME PLUS GAMMA GT #65055 & 56 | Emd Chemicals, Inc. | 1983-02-28 | Traditional | PDF ↗ |
| K830240 | ULTRAZYME PLUS GAMMA GT-MCA #65055-65056 | Emd Chemicals, Inc. | 1983-02-18 | Traditional | PDF ↗ |
| K830246 | CAST SHOE, CAST BOOT | Warm & Form, Orthopedic Materials | 1983-02-18 | Traditional | PDF ↗ |
| K823883 | ULTRAZYME PLUS GAMMA-GT, #64959/65032 | Emd Chemicals, Inc. | 1983-01-28 | Traditional | PDF ↗ |
| K820233 | ULTRAZYME PLUS GAMMA GT(65055-65056) | Harleco | 1982-02-12 | Traditional | PDF ↗ |
| K813041 | ULTRAZYME-GT, ITEM #64959 & 65032 | Harleco | 1981-11-10 | Traditional | PDF ↗ |
| K812296 | GAMMA GLUTAMY TRANSPEPTIDASE | Pointe Scientific, Inc., | 1981-08-31 | Traditional | PDF ↗ |
| K810434 | GAMMA-GT REAGENT SYSTEM | American Monitor Corp. | 1981-02-26 | Traditional | PDF ↗ |
| K800769 | Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST | Sclavo, Inc. | 1980-04-24 | Traditional | PDF ↗ |
| K780071 | GAMA-GPT REAGENT SET | Medical Analysis Systems, Inc. | 1978-02-14 | Traditional | PDF ↗ |
| K761090 | DIAGNOSTIC METHOD-8-GLUTAMYLTRANSFERASE | Technicon Instruments Corp. | 1976-12-02 | Traditional | PDF ↗ |
Product code JQB · Class I · Clinical Chemistry. Data: openFDA.