AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
FDA 510(k) clearance K991942 · decided 1999-08-24
Clearance details
- K-number
- K991942
- Device name
- AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
- Applicant
- Cogent Diagnotics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-09
- Decision date
- 1999-08-24
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- MLE
- Device class
- 2
- Regulation number
- 866.5110
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Midlothian, Scotland, GB
- 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 |
|---|---|---|
| QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA (K010558) | Inova Diagnostics, Inc. | 2001-04-03 |
| VARELISA PARIETAL CELL ANTIBODIES (K951206) | Elias U.S.A., Inc. | 1995-04-17 |
Recalls involving this device
No recalls on record reference this clearance.