HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM
FDA premarket approval P830018 · decided 1989-02-06
Approval details
- PMA number
- P830018
- Trade name
- HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Organon Teknika Corp.
- Date received
- 1983-04-05
- Decision date
- 1989-02-06
- Days to decision
- 2134 days
- Decision code
- APRL
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Durham, NC
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 |
|---|---|---|
| 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 |