CIS · Class II · 21 CFR 862.1100

FDA Product Code CIS: Hydrazone Colorimetry, Ast/sgot

Leading manufacturers include Instrumentation Laboratory CO, Clinical Data, Inc. and Roche Diagnostic Systems, Inc..

5
Total
5
Cleared
48d
Avg days
1979
Since

FDA 510(k) Cleared Hydrazone Colorimetry, Ast/sgot Devices (Product Code CIS)

5 devices
1–5 of 5
Cleared Sep 05, 2003
CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
K032027
Cholestech Corp.
Chemistry · 66d
Cleared Feb 16, 1990
COBAS READY AST REAGENT
K896238
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF SGOT (AST)
K854187
Clinical Data, Inc.
Chemistry · 41d
Cleared Oct 26, 1981
OPTIONAL TOTAL CA-MODULE FOR IL 504/508
K812872
Instrumentation Laboratory CO
Chemistry · 12d
Cleared Dec 06, 1979
ELVI SGOT & SGPT TRANSAMINASE
K792410
Volu Sol Medical Industries
Chemistry · 10d

About Product Code CIS - Regulatory Context