HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST
FDA premarket approval P840070/S001 · decided 1990-03-21
Approval details
- PMA number
- P840070
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Organon Teknika Corp.
- Date received
- 1989-08-25
- Decision date
- 1990-03-21
- Days to decision
- 208 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Durham, NC
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BACT/ALERT CSR (K003104) | Organon Teknika Corp. | 2000-10-20 |
| MDA D-DIMER (K000492) | Organon Teknika Corp. | 2000-06-07 |
| BACT/ALERT MB CULTURE BOTTLE (K000378) | Organon Teknika Corp. | 2000-03-02 |
| BACT/ALERT SV (K994343) | Organon Teknika Corp. | 2000-02-10 |
| BACT/ALERT SA (K993423) | Organon Teknika Corp. | 1999-12-15 |
| BACT/ALERT SN (K993421) | Organon Teknika Corp. | 1999-12-14 |
| BACT/ALERT MP PROCESS BOTTLE (K993576) | Organon Teknika Corp. | 1999-12-14 |
| BACT/ALERT FN (K992432) | Organon Teknika Corp. | 1999-09-24 |