GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60— 510(k) K961282
Substantially EquivalentDiagnostic Chemicals , Ltd.
FDA 510(k) clearance K961282 for GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60, Substantially Equivalent on 1996-06-21. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Chemicals , Ltd.
- Product code
- Code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottetown, P.E.I., CA
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