ALT/GPT REAGENT SET— 510(k) K844251
Substantially EquivalentSterling Biochemical, Inc.
FDA 510(k) clearance K844251 for ALT/GPT REAGENT SET, Substantially Equivalent on 1985-01-08. Applicant: Sterling Biochemical, Inc.. Device class: 1.
Clearance details
- Applicant
- Sterling Biochemical, 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
- Dearborn, MI, US
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