STA-HYBRID HEP CALIBRATOR— 510(k) K092937
Substantially EquivalentDiagnostica Stago, Inc.
FDA 510(k) clearance K092937 for STA-HYBRID HEP CALIBRATOR, Substantially Equivalent on 2010-08-02. Applicant: Diagnostica Stago, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostica Stago, Inc.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parisppany, NJ, US
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