510(k) K873135
- Device
- UNIFAST GAMMA-GT
- Applicant
- SCLAVO, INC.
- 510(k) number
- K873135
- Product code
- JQB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-09-04
- Date received
- 1987-08-10
- Regulation
- 862.1360
- Classification name
- Kinetic Method, Gamma-glutamyl Transpeptidase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBRA HOFMEISTER
- Address
- 5 Mansard Ct. Wayne NJ US 07470 07470
FDA Registration Numbers#
- 3013660430
- 8020316
- 3006198300
- 3003795116
- 1181121
- 9680746
- 2432235
- 9610529
- 1319809
- 2250051
- 1832216
- 8040374
- 2517506
- 3007662974
- 1827821
- 2939693
- 3008517993
- 3003593973
- 2050010
- 3010825766
- 2085064
- 1616487
- 9610126
- 1220972
- 1319681
- 3021841051
- 3000148879
- 3004192065
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JQB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974000 | Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 | Diagnostic Chemicals , Ltd. | 1997-11-04 |
| K973157 | LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET | Pointe Scientific, Inc., | 1997-10-10 |
| K971466 | SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) | Carolina Liquid Chemistries Corp. | 1997-05-06 |
| K964457 | ROCHE COBAS IBTEGRA REAGENT CASSETTES | Roche Diagnostic Systems, Inc. | 1997-01-13 |
| K964916 | GAMMA-GLUTAMYL TRANSPEPTIDASE | Derma Media Lab., Inc. | 1997-01-10 |
| K955770 | GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM | Abaxis, Inc. | 1996-09-09 |
| K945800 | Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 | Diagnostic Chemicals , Ltd. | 1995-06-09 |
| K946192 | HICHEM Y-GT REAGENT KIT | Hichem Diagnostics | 1995-05-02 |
| K942962 | GGT QVET | Prisma Systems | 1994-12-07 |
| K935984 | GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 | Sigma Diagnostics, Inc. | 1994-07-20 |
| K941315 | STANBIO Y-GT (LIQUICOLOR) TEST SET | Stanbio Laboratory | 1994-07-14 |
| K935177 | GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | Em Diagnostic Systems, Inc. | 1993-12-16 |
| K931958 | SYNERMED GGT REAGENT KIT | Synermed, Inc. | 1993-09-08 |
| K925337 | OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT | Olympus Corp. | 1993-01-26 |
| K924246 | ROCHE REAGENT FOR GGT | Roche Diagnostic Systems, Inc. | 1992-11-18 |
Legacy Summary#
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FDA Review#
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