PLUS CHEM, DETERMINATION OF ALT (GPT)— 510(k) K791084
Substantially EquivalentSmithkline Diagnostics, Inc.
FDA 510(k) clearance K791084 for PLUS CHEM, DETERMINATION OF ALT (GPT), Substantially Equivalent on 1979-07-17. Applicant: Smithkline Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Smithkline Diagnostics, Inc.
- 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
- Walker, MI, US
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