VISION (TM) GGTP
FDA 510(k) clearance K864208 · decided 1986-11-24
Clearance details
- K-number
- K864208
- Device name
- VISION (TM) GGTP
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1986-10-27
- Decision date
- 1986-11-24
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- JPZ
- Device class
- 1
- Regulation number
- 862.1360
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CARESIDE GGT (K020486) | Careside, Inc. | 2002-07-01 |
| DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE (K961919) | Data Medical Associates, Inc. | 1996-07-01 |
| GAMMA-GT (K923509) | Randox Laboratories, Ltd. | 1992-12-03 |
| KING DIAGNOSTICS GAMMA GT REAGENT (K923091) | King Diagnostics, Inc. | 1992-09-09 |
| GGT REAGENT (K905618) | Amresco, Inc. | 1991-02-26 |
| ROCHE COBAS READY GGT REAGENT (K903304) | Roche Diagnostic Systems, Inc. | 1990-10-12 |
| ELITECH GAMMA GT TEST KIT (K901090) | Elite Technology, Inc. | 1990-03-29 |
| WAKO(TM) AUTOKIT GAMMA-GT (K895984) | Wako Chemicals USA, Inc. | 1989-11-08 |
| GAMMA GLUTAMYL TRANSFERASE REAGENT SET (K881239) | Tech-Neal Scientific, Inc. | 1988-05-31 |
| MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) (K874903) | Simmler, Inc. | 1988-02-11 |
| GAMMA GLUTAMYLTRANSFERASE REAGENT (K871979) | Intersect Systems, Inc. | 1987-06-11 |
| GAMMA GLUTAMYL TRANSFERASE PROCEDURE (K863586) | Data Medical Associates, Inc. | 1986-10-03 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |