CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17— 510(k) K000055
Substantially EquivalentDiagnostic Chemicals , Ltd.
FDA 510(k) clearance K000055 for CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17, Substantially Equivalent on 2000-02-18. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Chemicals , Ltd.
- Product code
- Code CGX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottetown, P.E., CA
Recent devices under product code CGX
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