SYN ELISA MICRO ALBUMIN— 510(k) K920216
Substantially EquivalentElias U.S.A., Inc.
FDA 510(k) clearance K920216 for SYN ELISA MICRO ALBUMIN, Substantially Equivalent on 1992-03-11. Applicant: Elias U.S.A., Inc.. Device class: 1.
Clearance details
- Applicant
- Elias U.S.A., Inc.
- Product code
- Code JIR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1645
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Osceola, WI, US
Recent devices under product code JIR
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