KHE · Class II · 21 CFR 864.6550

FDA Product Code KHE: Reagent, Occult Blood

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

97
Total
97
Cleared
135d
Avg days
1976
Since
97 devices
73–96 of 97
Cleared Sep 05, 1984
OCCULT BLOOD TEST
K842137
Breit Laboratories, Inc.
Hematology · 98d
Cleared Aug 16, 1984
ACCU-CULT FECAL OCCULT BLOOD TEST
K840904
Applied Medical Devices, Inc.
Hematology · 170d
Cleared Aug 10, 1984
HELENA COLOSCREEN SELF-TEST
K840903
Helena Laboratories
Hematology · 164d
Cleared Aug 02, 1984
EARLY DETECTOR
K833369
Warner-Lambert Co.
Hematology · 310d
Cleared Feb 27, 1984
HEMOCCULT-C
K832311
Menley & James Laboratories
Chemistry · 228d
Cleared Jan 27, 1984
PROPPER SERACULT
K834297
Propper Mfg. Co., Inc.
Hematology · 50d
Cleared Jan 13, 1984
HELENA BIO STRIP OB
K834456
Helena Laboratories
Chemistry · 25d
Cleared Nov 21, 1983
COLOSCREEN V.P.I.
K832864
Helena Laboratories
Immunology · 90d
Cleared Jul 07, 1983
OCCULT-ALERT
K830919
Beta Med Pharmaceuticals, Inc.
Chemistry · 107d
Cleared Mar 07, 1983
FECAL OCCULT SLIDE TEST KIT
K830223
Cambridge Chemical Products, Inc.
Chemistry · 42d
Cleared Oct 18, 1982
HEMOTECT
K822731
Bio-Chem Laboratories
Hematology · 35d
Cleared Oct 08, 1982
GASTROCCULT TM
K821884
Smithkline Diagnostics, Inc.
Hematology · 105d
Cleared Jul 02, 1982
FLEET DETECTATEST
K812728
C.B. Fleet Co., Inc.
Hematology · 277d
Cleared Mar 04, 1982
FE-CULT PLUS
K820072
Gamma Biologicals, Inc.
Hematology · 51d
Cleared Jan 28, 1982
SERACULT OCCULT BLOOF TEST
K813204
Propper Mfg. Co., Inc.
Hematology · 76d
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 08, 1981
HOME HEALTH CHEKUP KIT
K810488
Healthkit
Hematology · 74d
Cleared May 02, 1980
HELENA COLOCHECK
K800433
Helena Laboratories
Hematology · 65d
Cleared Jan 24, 1980
HELENA COLOSCREEN
K792655
Helena Laboratories
Hematology · 29d
Cleared Jun 30, 1978
FECATEST
K780564
Otto C. Watzka
Hematology · 85d
Cleared May 03, 1978
HEMO FEC
K780214
Boehringer Mannheim Corp.
Hematology · 84d
Cleared Feb 08, 1977
CAMCO R PAK-GUAIAC
K770153
Cambridge Chemical Products, Inc.
Hematology · 15d