CKD · Class I · 21 CFR 862.1030

FDA Product Code CKD: Hydrazone Colorimetry, Alt/sgpt

Leading manufacturers include Roche Diagnostic Systems, Inc., Ortho Diagnostic Systems, Inc. and Medical Specialties, Inc..

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 May 16, 1995
ORTHO ALT MICROWELL TEST SYSTEM
K941192
Ortho Diagnostic Systems, Inc.
Chemistry · 428d
Cleared Feb 16, 1990
COBAS READY ALT REAGENT
K896237
Roche Diagnostic Systems, Inc.
Chemistry · 108d
Cleared Oct 13, 1988
ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)
K883387
Tech-Co, Inc.
Chemistry · 64d
Cleared Dec 04, 1986
REFLOTRON(R) ALT (GPT)
K864082
Boehringer Mannheim Corp.
Chemistry · 45d
Cleared Apr 03, 1986
SGPT (ALT) REAGENT SET (COLORIMETRIC)
K860485
Sterling Diagnostics, Inc.
Chemistry · 52d
Cleared May 01, 1984
SGPT REAGENT SET
K841059
Medical Specialties, Inc.
Chemistry · 50d

About Product Code CKD - Regulatory Context