GONO-CELL
FDA 510(k) clearance K782013 · decided 1979-04-23
Clearance details
- K-number
- K782013
- Device name
- GONO-CELL
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1978-12-05
- Decision date
- 1979-04-23
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- JSX
- Device class
- 1
- Regulation number
- 866.2660
- 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 |
|---|---|---|
| GONOPOX TEST KIT (K960759) | Medtex Laboratories, Inc. | 1996-09-18 |
| NIZYME TEST KIT (K923566) | Remel Co. | 1992-11-02 |
| VISI-NEISSERIA (K913456) | Kev Connecticut Diagnostics, Inc. | 1991-10-11 |
| XACT NEISSERIA (K880511) | Austin Biological Laboratories | 1988-08-25 |
| MODIFIED IDS RAPID NH SYSTEM (K881501) | Innovative Diagnostic Systems, Inc. | 1988-05-18 |
| NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST (K870117) | Pro-Lab, Inc. | 1987-03-20 |
| QUAD FERM + (K853544) | Analytical Products, Inc. | 1985-09-05 |
| NEISSERIA - KWIK PLUS (K852998) | Micro-Bio-Logics | 1985-07-23 |
| GONI-KIT (K852582) | Culture Kits, Inc. | 1985-07-12 |
| PHADEBACK G.C. POSITIVE CONTROLS (K833307) | Pharmacia, Inc. | 1983-12-27 |
| GONOCHEK-II (K833180) | E-Y Laboratories, Inc. | 1983-11-14 |
| NEISSERIA IDENTIFICATION DISCS (K830364) | Oxoid U.S.A., Inc. | 1983-03-08 |
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 |