ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30— 510(k) K974001
Substantially EquivalentDiagnostic Chemicals , Ltd.
FDA 510(k) clearance K974001 for ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30, Substantially Equivalent on 1997-11-13. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Chemicals , Ltd.
- 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
- Charlottetown, P.E.I., CA
Recent devices under product code CIT
view all- K093883 — AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-
- 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 Diagnostic Chemicals , Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.