SYNELISA U1-SNRNP (68KDA)-ANTIBODIES— 510(k) K930142
Substantially EquivalentElias U.S.A., Inc.
FDA 510(k) clearance K930142 for SYNELISA U1-SNRNP (68KDA)-ANTIBODIES, Substantially Equivalent on 1993-05-11. Applicant: Elias U.S.A., Inc.. Device class: 2.
Clearance details
- Applicant
- Elias U.S.A., Inc.
- Product code
- Code LKO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Osceola, WI, US
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More clearances from Elias U.S.A., Inc.
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