ALT (GPT) - ALANINE AMINOTRANSFERASE— 510(k) K923510
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K923510 for ALT (GPT) - ALANINE AMINOTRANSFERASE, Substantially Equivalent on 1992-11-16. Applicant: Randox Laboratories, Ltd.. Device class: 1.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- 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
- Antrim, N. Ireland, IR
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More clearances from Randox Laboratories, Ltd.
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