GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)
FDA 510(k) clearance K812078 · decided 1981-07-23
Clearance details
- K-number
- K812078
- Device name
- GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)
- Applicant
- Abbott Laboratories
- Decision
- Unknown
- Date received
- 1981-07-23
- Decision date
- 1981-07-23
- Days to decision
- 0 days
- Clearance type
- Traditional
- Product code
- JTY
- Device class
- 2
- Regulation number
- 866.2410
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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 |
|---|---|---|
| InTray GC (K210511) | Biomed Diagnostics Incorporated | 2021-10-20 |
| INTRAY GC (K993033) | Biomed Diagnostics, Inc. | 1999-12-16 |
| GC BASE W/ 1% GCHI (K954986) | Remel, L.P. | 1996-02-16 |
| CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA (K950196) | Bioclinical Systems, Inc. | 1995-06-30 |
| MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR (K933122) | Bioclinical Systems, Inc. | 1994-02-09 |
| MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR (K933121) | Bioclinical Systems, Inc. | 1994-02-03 |
| THAYER MARTIN, MODIFIED PILL POCKET (K934331) | Hardy Diagnostics | 1993-12-21 |
| TRANSGROW (K934330) | Hardy Diagnostics | 1993-12-17 |
| MARTIN LEWIS WITH LINOCMYCIN (K931864) | Hardy Diagnostics | 1993-12-15 |
| CASMAN MEDIUM BASE (K881527) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| PROTEOSE NO. 3 AGAR (K881552) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 (K871541) | Gibco Laboratories Life Technologies, Inc. | 1987-04-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S032) | Abbott Laboratories | 2026-05-11 |
| ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92) (P910007/S068) | Abbott Laboratories | 2026-02-23 |
| ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) (P980007/S056) | Abbott Laboratories | 2026-02-12 |
| ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92) (P910007/S067) | Abbott Laboratories | 2026-02-12 |
| ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S031) | Abbott Laboratories | 2026-02-12 |
| 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 |