INDIRECT FLUORESCENT ANTIBODY REAGENTS
FDA 510(k) clearance K831026 · decided 1983-06-22
Clearance details
- K-number
- K831026
- Device name
- INDIRECT FLUORESCENT ANTIBODY REAGENTS
- Applicant
- Zeus Technologies
- Decision
- Substantially Equivalent
- Date received
- 1983-03-30
- Decision date
- 1983-06-22
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- LHL
- Device class
- 2
- Regulation number
- 866.3300
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| FLUORO-CEP{R} ESTROGEN ASSAY REAGENT (P860015/S001) | Zeus Technologies | 1992-04-21 |
| FLUORO-CEP{R} ESTROGEN ASSAY REAGENT (P860015/S002) | Zeus Technologies | 1992-04-17 |
| FLUORO-CEP{R} ESTROGEN ASSAY REAGENT (P860015) | Zeus Technologies | 1988-02-29 |