CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]
FDA premarket approval P790032/S002 · decided 1991-03-28
Approval details
- PMA number
- P790032
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Incstar Corp.
- Date received
- 1990-12-24
- Decision date
- 1991-03-28
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Stillwater, MN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY (K963289) | Incstar Corp. | 1997-05-01 |
| INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) (K963296) | Incstar Corp. | 1996-12-16 |
| INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) (K963297) | Incstar Corp. | 1996-12-16 |
| INCSTAR RUBELLA IGG ELISA ASSAY (K960367) | Incstar Corp. | 1996-10-24 |
| INCSTAR RUBELLA IGG FAST ELISA ASSAY (K960358) | Incstar Corp. | 1996-10-24 |
| INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 (K960434) | Incstar Corp. | 1996-10-17 |
| INCSTAR 25-HYDROXYVITMIN D 1251 RIA (K953567) | Incstar Corp. | 1996-09-25 |
| INCSTAR HSZ I/II IGG ELISA ASSAY (K955363) | Incstar Corp. | 1996-07-24 |