SYNELISA CORTISOL— 510(k) K931177
Substantially EquivalentElias U.S.A., Inc.
FDA 510(k) clearance K931177 for SYNELISA CORTISOL, Substantially Equivalent on 1993-09-27. Applicant: Elias U.S.A., Inc.. Device class: 2.
Clearance details
- Applicant
- Elias U.S.A., Inc.
- Product code
- Code CGR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1205
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Osceola, WI, US
Recent devices under product code CGR
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