SYNELISA CARDIOLIPIN ANTIBODIES— 510(k) K935288
Substantially EquivalentElias U.S.A., Inc.
FDA 510(k) clearance K935288 for SYNELISA CARDIOLIPIN ANTIBODIES, Substantially Equivalent on 1994-01-24. Applicant: Elias U.S.A., Inc.. Device class: 2.
Clearance details
- Applicant
- Elias U.S.A., Inc.
- Product code
- Code MID
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Osceola, WI, US
Recent devices under product code MID
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