AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30— 510(k) K001285
Substantially EquivalentDiagnostic Chemicals , Ltd.
FDA 510(k) clearance K001285 for AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30, Substantially Equivalent on 2000-06-02. Applicant: Diagnostic Chemicals , Ltd.. Device class: 1.
Clearance details
- Applicant
- Diagnostic Chemicals , Ltd.
- Product code
- Code JIF
- Device class
- Class 1
- Regulation
- 21 CFR 862.1065
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottetown, P.E., CA
Recent devices under product code JIF
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