ALANINE AMINOTRANSFERASE ASSAY KIT— 510(k) K842241
Substantially EquivalentDiagnostic Chemicals, Ltd. (Usa)
FDA 510(k) clearance K842241 for ALANINE AMINOTRANSFERASE ASSAY KIT, Substantially Equivalent on 1984-07-18. 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
- Canada, US
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