CA 125 ANTIBODY RIA
FDA premarket approval P850009/S005 · decided 1992-07-15
Approval details
- PMA number
- P850009
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CA 125 ANTIBODY RIA
- Generic name
- TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
- Applicant
- Centocor, Inc.
- Date received
- 1992-01-23
- Decision date
- 1992-07-15
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- LTK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Malvern, PA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CENTOCOR CA 15-3 RIA MODEL NO. 800-033 (K963803) | Centocor, Inc. | 1997-05-23 |
| CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT (K954997) | Centocor, Inc. | 1996-01-24 |
| FITC ANTI-RABIES MONOCLONAL GLOBULIN (K820499) | Centocor, Inc. | 1982-04-16 |