VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY
FDA 510(k) clearance K926422 · decided 1993-06-02
Clearance details
- K-number
- K926422
- Device name
- VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1992-12-23
- Decision date
- 1993-06-02
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- GGJ
- Device class
- 1
- Regulation number
- 864.8200
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.