AST/SGOT LIQUID REAGENT - KINETIC METHOD— 510(k) K981650
Substantially EquivalentTeco Diagnostics
FDA 510(k) clearance K981650 for AST/SGOT LIQUID REAGENT - KINETIC METHOD, Substantially Equivalent on 1998-06-29. Applicant: Teco Diagnostics. Device class: 2.
Clearance details
- Applicant
- Teco Diagnostics
- 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
- Anaheim, CA, US
Recent devices under product code CIT
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- K080485 — ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
- K071525 — ACTIVATED ASPARTATE AMINOTRANSFERASE
- K071580 — AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
- K071211 — COBAS C 111 ANALYZER
More clearances from Teco Diagnostics
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