ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS— 510(k) K080485
Substantially EquivalentDiasys Diagnostics Systems GmbH
FDA 510(k) clearance K080485 for ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS, Substantially Equivalent on 2008-12-04. Applicant: Diasys Diagnostics Systems GmbH. Device class: 2.
Clearance details
- Applicant
- Diasys Diagnostics Systems GmbH
- 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
- Holzheim, Rheinland-Pfalz, DE
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-
- K071525 — ACTIVATED ASPARTATE AMINOTRANSFERASE
- K071580 — AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
- K071211 — COBAS C 111 ANALYZER
- K060318 — HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.