FLUORO-CEP (R) PROGESTERONE
FDA premarket approval P900025 · decided 1990-09-26
Approval details
- PMA number
- P900025
- Trade name
- FLUORO-CEP (R) PROGESTERONE
- Generic name
- KIT, ASSAY, PROGESTERONE RECEPTOR
- Applicant
- Zeus Scientific, Inc.
- Date received
- 1990-04-11
- Decision date
- 1990-09-26
- Days to decision
- 168 days
- Decision code
- APWD
- Product code
- LPI
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Branchburg, NJ
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Zeus IFA ANA HEp-2 Test System, Zeus dIFine (K201956) | Zeus Scientific, Inc. | 2022-04-29 |
| ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System (K190907) | Zeus Scientific, Inc. | 2019-07-29 |
| ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System (K191398) | Zeus Scientific, Inc. | 2019-07-29 |
| ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System (K191240) | Zeus Scientific, Inc. | 2019-07-29 |
| ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM (K113397) | Zeus Scientific, Inc. | 2012-07-26 |
| ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM (K102425) | Zeus Scientific, Inc. | 2011-12-12 |
| ZEUS ELISA HSV GG-2 IGG TEST SYSTEM (K103603) | Zeus Scientific, Inc. | 2011-05-20 |
| ZEUS ELISA HSV GC-I IGG TEST SYSTEM (K103363) | Zeus Scientific, Inc. | 2011-04-26 |