VARELISA DSDNA ANTIBODIES (FARR VERSION)— 510(k) K950031
Substantially EquivalentElias U.S.A., Inc.
FDA 510(k) clearance K950031 for VARELISA DSDNA ANTIBODIES (FARR VERSION), Substantially Equivalent on 1995-03-10. Applicant: Elias U.S.A., Inc.. Device class: 2.
Clearance details
- Applicant
- Elias U.S.A., Inc.
- Product code
- Code LRM
- 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
Recent devices under product code LRM
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