ABBOTT PGR-EIA MONOCLONAL
FDA premarket approval P900013/S001 · decided 1995-07-07
Approval details
- PMA number
- P900013
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ABBOTT PGR-EIA MONOCLONAL
- Generic name
- KIT, ASSAY, PROGESTERONE RECEPTOR
- Applicant
- Abbott Laboratories
- Date received
- 1995-05-25
- Decision date
- 1995-07-07
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LPI
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- MINOR LABELING CHANGES TO ASSIST USERS IN AVOIDING INTERFERENCE BY METHYLENE BLUE & SIMILAR DYES.CHANGES:REVISED INSTRUCTIONS ON SPECIMEN COLLECTION & SLIDE PREPARATION,ADDING REFERENCE ON THE EFFECT OF METHYLENE BLUE ON ESTROGEN RECEPTORS
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 |
|---|---|---|
| Anti-HCV Next (K252424) | Abbott Laboratories | 2026-04-28 |
| ARCHITECT iGentamicin (K243500) | Abbott Laboratories | 2025-07-09 |
| Alinity i Rubella IgG (K243168) | Abbott Laboratories | 2025-06-20 |
| Alinity h-series System (K243283) | Abbott Laboratories | 2025-02-20 |
| Alinity i Toxo IgM (K233932) | Abbott Laboratories | 2024-08-30 |
| TBI (K232669) | Abbott Laboratories | 2023-09-29 |
| HAVAb IgG II (K222850) | Abbott Laboratories | 2023-08-10 |
| Alinity h-series System (K220031) | Abbott Laboratories | 2023-08-04 |