CKD · Class I · 21 CFR 862.1030

FDA Product Code CKD: Hydrazone Colorimetry, Alt/sgpt

Leading manufacturers include Roche Diagnostic Systems, Inc. and Boehringer Mannheim Corp..

11
Total
11
Cleared
92d
Avg days
1982
Since

FDA 510(k) Cleared Hydrazone Colorimetry, Alt/sgpt Devices (Product Code CKD)

11 devices
1–11 of 11
Cleared Feb 16, 1990
COBAS READY ALT REAGENT
K896237
Roche Diagnostic Systems, Inc.
Chemistry · 108d
Cleared Dec 04, 1986
REFLOTRON(R) ALT (GPT)
K864082
Boehringer Mannheim Corp.
Chemistry · 45d

About Product Code CKD - Regulatory Context