NORMAL AND HYPERGAMMA CONTROL SERUM— 510(k) K040925
Substantially EquivalentSebia
FDA 510(k) clearance K040925 for NORMAL AND HYPERGAMMA CONTROL SERUM, Substantially Equivalent on 2004-04-28. Applicant: Sebia. Device class: 1.
Clearance details
- Applicant
- Sebia
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chelsea, MI, US
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