HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51— 510(k) K980770
Substantially EquivalentDiagnostic Chemicals , Ltd.
FDA 510(k) clearance K980770 for HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51, Substantially Equivalent on 1998-04-21. Applicant: Diagnostic Chemicals , Ltd.. Device class: 1.
Clearance details
- Applicant
- Diagnostic Chemicals , Ltd.
- Product code
- Code LBR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottetown, P.E.I., CA
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More clearances from Diagnostic Chemicals , Ltd.
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