ASPARTATE AMINOTRANFERASE (AST)— 510(k) K896000
Substantially EquivalentAmerican Monitor Corp.
FDA 510(k) clearance K896000 for ASPARTATE AMINOTRANFERASE (AST), Substantially Equivalent on 1990-01-11. Applicant: American Monitor Corp.. Device class: 2.
Clearance details
- Applicant
- American Monitor Corp.
- Product code
- Code CIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1100
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code CIT
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- K071525 — ACTIVATED ASPARTATE AMINOTRANSFERASE
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More clearances from American Monitor Corp.
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