FLUORO-CEP{R} ESTROGEN ASSAY REAGENT
FDA premarket approval P860015/S001 · decided 1992-04-21
Approval details
- PMA number
- P860015
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FLUORO-CEP{R} ESTROGEN ASSAY REAGENT
- Generic name
- KIT, ASSAY, ESTROGEN RECEPTOR
- Applicant
- Zeus Technologies
- Date received
- 1991-12-11
- Decision date
- 1992-04-21
- Days to decision
- 132 days
- Decision code
- APPR
- Product code
- LPJ
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Raritan, NJ
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| INDIRECT FLUORESCENT ANTIBODY MYCO (K840012) | Zeus Technologies | 1984-02-27 |
| INDIRECT FLUORESCENT ANTIBODY REAGENTS (K831026) | Zeus Technologies | 1983-06-22 |
| VERI-STAPH (K830783) | Zeus Technologies | 1983-04-08 |
| DIRECT FA CONJUGATE FOR LEGIONELLA SPP (K822859) | Zeus Technologies | 1983-02-16 |