CEX · Class II · 21 CFR 862.1445

FDA Product Code CEX: Chromatographic Separation, Lactate Dehydrogenase Isoenzymes

Leading manufacturers include Union Carbide Corp., Harleco Diagnostics and Helena Laboratories.

8
Total
8
Cleared
67d
Avg days
1977
Since

FDA 510(k) Cleared Chromatographic Separation, Lactate Dehydrogenase Isoenzymes Devices (Product Code CEX)

8 devices
1–8 of 8
Cleared Sep 16, 1987
LACTATE DEHYDROGENASE ISOENZYME 1
K872891
Data Medical Associates, Inc.
Chemistry · 55d
Cleared May 10, 1985
LD-1(IMMUNO) SEPARATION SET
K851521
Seragen Diagnostics, Inc.
Chemistry · 25d
Cleared Dec 22, 1982
TITAN GEL LDH ISOENZYME KIT
K821983
Helena Laboratories
Chemistry · 169d
Cleared Jul 14, 1982
ULTRACHEM T.P.
K821879
Harleco Diagnostics
Chemistry · 19d
Cleared Feb 13, 1980
CENTRIFICHEM CREATININE
K800129
Union Carbide Corp.
Chemistry · 26d

About Product Code CEX - Regulatory Context