AB-CORE K HEPATITIS B CORE ANTIGEN 125I
FDA premarket approval P850044/S003 · decided 1987-02-17
Approval details
- PMA number
- P850044
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AB-CORE K HEPATITIS B CORE ANTIGEN 125I
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Sorin Biomedica, Fiat, USA, Inc.
- Date received
- 1986-11-18
- Decision date
- 1987-02-17
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Ny, NY
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS (K931444) | Sorin Biomedica, Fiat, USA, Inc. | 1994-05-27 |
| STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE (K925661) | Sorin Biomedica, Fiat, USA, Inc. | 1993-05-18 |
| SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE (K925615) | Sorin Biomedica, Fiat, USA, Inc. | 1993-03-26 |
| BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS (K925369) | Sorin Biomedica, Fiat, USA, Inc. | 1993-03-26 |
| STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR (K924354) | Sorin Biomedica, Fiat, USA, Inc. | 1993-02-18 |
| STOCKERT 1/4 BUBBLE SENSOR (K925541) | Sorin Biomedica, Fiat, USA, Inc. | 1993-02-02 |
| SORIN MONOLYRH INTEGRATED MEMBRANE LUNG (K922933) | Sorin Biomedica, Fiat, USA, Inc. | 1992-11-30 |
| S80 IMPLANTABLE CARDIAC PACING LEAD (K854963) | Sorin Biomedica, Fiat, USA, Inc. | 1986-06-24 |