KHE · Class II · 21 CFR 864.6550

FDA Product Code KHE: Reagent, Occult Blood

Leading manufacturers include Helena Laboratories, Smithkline Diagnostics, Inc. and Immunostics Inc.,.

97
Total
97
Cleared
135d
Avg days
1976
Since
97 devices
49–72 of 97
Cleared Dec 10, 1981
UROPAPER EIKEG
K811815
Syn-Kit, Inc.
Hematology · 167d
Cleared Nov 02, 1981
FE-CULT PLUS
K811752
Gamma Biologicals, Inc.
Toxicology · 133d
Cleared Oct 23, 1981
HELENA COLOSCREEN METHOD
K812428
Helena Laboratories
Hematology · 59d
Cleared May 02, 1980
HELENA COLOCHECK
K800433
Helena Laboratories
Hematology · 65d
Cleared Jan 24, 1980
HELENA COLOSCREEN
K792655
Helena Laboratories
Hematology · 29d
Cleared May 03, 1978
HEMO FEC
K780214
Boehringer Mannheim Corp.
Hematology · 84d