SYNELISA TG ANTIBODIES/TPO ANTIBODIES— 510(k) K933123
Substantially EquivalentElias U.S.A., Inc.
FDA 510(k) clearance K933123 for SYNELISA TG ANTIBODIES/TPO ANTIBODIES, Substantially Equivalent on 1993-08-23. Applicant: Elias U.S.A., Inc.. Device class: 1.
Clearance details
- Applicant
- Elias U.S.A., Inc.
- Product code
- Code JZS
- Device class
- Class 1
- Regulation
- 21 CFR 866.4500
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Osceola, WI, US
Recent devices under product code JZS
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