MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT— 510(k) K862833
Substantially EquivalentDiagnostic Chemicals, Ltd. (Usa)
FDA 510(k) clearance K862833 for MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT, Substantially Equivalent on 1986-08-19. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 1.
Clearance details
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
- Product code
- Code CKA
- Device class
- Class 1
- Regulation
- 21 CFR 862.1030
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottestown,Pei,Canada, CA
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