WIENER LAB GOT (AST) UV AA LIQUIDA— 510(k) K023551
Substantially EquivalentWiener Laboratories Saic
FDA 510(k) clearance K023551 for WIENER LAB GOT (AST) UV AA LIQUIDA, Substantially Equivalent on 2002-12-09. Applicant: Wiener Laboratories Saic. Device class: 2.
Clearance details
- Applicant
- Wiener Laboratories Saic
- 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
- Rosario, Santa Fe, AR
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 Wiener Laboratories Saic
view all- K023889 — WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
- K024305 — WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006
- K023992 — WIENER LAB COLINESTERASA AA
- K024116 — WIENER LAB. BILIRUBINA DIRECT AA
- K023744 — WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
Data sourced from openFDA. This site is unofficial and independent of the FDA.