CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91— 510(k) K051757
Substantially EquivalentDiagnostic Chemicals , Ltd.
FDA 510(k) clearance K051757 for CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91, Substantially Equivalent on 2005-11-10. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Chemicals , Ltd.
- Product code
- Code CJY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottetown, P.E., CA
Recent devices under product code CJY
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