JHX · Class II · 21 CFR 862.1215

FDA Product Code JHX: Fluorometric Method, Cpk Or Isoenzymes

Leading manufacturers include Beckman Coulter, Inc., Diagnostic Products Corp. and Corning Medical & Scientific.

48
Total
48
Cleared
73d
Avg days
1976
Since
48 devices
25–48 of 48
Cleared Jul 14, 1980
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
K801318
Helena Laboratories
Chemistry · 36d
Cleared Mar 20, 1980
CORNING TRANSPHOR
K800544
Corning Medical & Scientific
Chemistry · 10d
Cleared Jan 16, 1980
RIA-QUANT CK-MB TEST KIT
K792504
Mallinckrodt Critical Care
Chemistry · 43d
Cleared Mar 21, 1979
BUFFER, CORNING MOPSO
K790294
Corning Medical & Scientific
Chemistry · 41d
Cleared Sep 02, 1977
3-(N-MORPHOLINS)-PROPANE SULFONIC ACID
K771324
Corning Medical & Scientific
Chemistry · 46d
Cleared Oct 29, 1976
SIGMA PROCEDURE NO. 745 - EP.REAGENT SY
K760591
Sigma Chemical Co.
Chemistry · 52d