GESTATE SLIDE EIKEN KIT AGG. METHOD HUM— 510(k) K802450
Substantially EquivalentSyn-Kit, Inc.
FDA 510(k) clearance K802450 for GESTATE SLIDE EIKEN KIT AGG. METHOD HUM, Substantially Equivalent on 1980-10-31. Applicant: Syn-Kit, Inc..
Clearance details
- Applicant
- Syn-Kit, Inc.
- Product code
- Code JHJ
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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