JHT · Class II · 21 CFR 862.1215

FDA Product Code JHT: Chromatographic Separation, Cpk Isoenzymes

Leading manufacturers include Helena Laboratories and Boehringer Mannheim Corp..

21
Total
21
Cleared
71d
Avg days
1976
Since

FDA 510(k) Cleared Chromatographic Separation, Cpk Isoenzymes Devices (Product Code JHT)

21 devices
1–21 of 21
Cleared Apr 12, 1993
CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305
K930359
Helena Laboratories
Chemistry · 76d
Cleared Feb 16, 1990
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
K896170
Helena Laboratories
Chemistry · 114d
Cleared Nov 01, 1982
TITAN GEL CPK ISOENZYME SYSTEM
K822124
Helena Laboratories
Chemistry · 105d
Cleared Aug 22, 1977
CK-MB
K771497
Boehringer Mannheim Corp.
Chemistry · 17d

About Product Code JHT - Regulatory Context