ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S— 510(k) K851308
Substantially EquivalentTechnicon Instruments Corp.
FDA 510(k) clearance K851308 for ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S, Substantially Equivalent on 1985-04-17. Applicant: Technicon Instruments Corp.. Device class: 2.
Clearance details
- Applicant
- Technicon Instruments Corp.
- Product code
- Code CIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1035
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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