510(k) K926422
- Device
- VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY
- Applicant
- SYVA CO.
- 510(k) number
- K926422
- Product code
- GGJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-06-02
- Date received
- 1992-12-23
- Regulation
- 864.8200
- Classification name
- Fluid, Diluting, White-cell
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL L ROGERS
- Address
- P.O. Box 49013 San Jose CA US 95161 95161
FDA Registration Numbers#
- 3002809144
- 3006365273
- 3014150341
- 2013736
- 3008344661
- 1419699
- 3016438761
- 3005333358
- 1625587
- 1125908
Source Documents#
Legacy Summary#
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FDA Review#
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