THYROID CALIBRATOR— 510(k) K970389
Substantially EquivalentDade Chemistry Systems, Inc.
FDA 510(k) clearance K970389 for THYROID CALIBRATOR, Substantially Equivalent on 1997-02-18. Applicant: Dade Chemistry Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Chemistry Systems, 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
- Glasgow, DE, US
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