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
49–72 of 97
Cleared Nov 05, 1990
MONOHAEM (FECAL OCCULT BLOOD TEST)
K901064
Silenus Laboratories Proprietary , Ltd.
Hematology · 243d
Cleared Jul 27, 1990
HEMA-SCREEN
K902360
Immunostics Co., Inc.
Hematology · 59d
Cleared Jan 25, 1990
RESUBMITTED FECATWIN SENSITIVE - FECA-EIA
K896474
Labsystems, Inc.
Hematology · 73d
Cleared Apr 18, 1989
HEMAWIPE SYSTEM, THE CIVILIZED TEST
K884206
Labeltape Meditect, Inc.
Hematology · 194d
Cleared Oct 31, 1988
IMMUNOCCULT-LXI
K883432
Intl. Immunoassay Laboratories, Inc.
Hematology · 77d
Cleared Sep 30, 1988
COLORECTAL CANCER RISK DETECTOR (TM)
K874180
Pearce Clinical Laboratories, Inc.
Hematology · 352d
Cleared Sep 30, 1988
HELENA COLOCARE
K882799
Helena Laboratories
Hematology · 86d
Cleared Jul 08, 1988
IMMUNOCCULT EIA TEST KIT
K871143
Intl. Immunoassay Laboratories, Inc.
Hematology · 473d
Cleared Jul 08, 1988
HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD
K881907
Enzo Biochem, Inc.
Hematology · 63d
Cleared May 23, 1988
HEMOCCULT SENSITIVE TEST
K880499
Smithkline Diagnostics, Inc.
Hematology · 108d
Cleared May 13, 1988
REVISED IMMUDIA HEM-SP
K874482
Schiff & Co.
Hematology · 206d
Cleared Feb 11, 1988
WAKO(TM) PRETEST 6A
K873409
Wako Chemicals USA, Inc.
Chemistry · 170d
Cleared Dec 09, 1986
HEMOCCULT WIPE TEST
K862849
Smithkline Diagnostics, Inc.
Hematology · 133d
Cleared Nov 06, 1986
NATURAL DETECTOR SYSTEM
K861731
U.S. Health Resources Corp.
Hematology · 184d
Cleared May 06, 1986
BIOTEL (TM)/ KIDNEY
K855237
American Diagnostic Corp.
Hematology · 126d
Cleared Apr 09, 1986
EZ DETECH-URINE BLOOD TEST STICKS
K854358
Self Care Systems, Inc.
Chemistry · 162d
Cleared Apr 07, 1986
MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL
K860028
Self Care Systems, Inc.
Hematology · 94d
Cleared Mar 03, 1986
DETECTACULT
K854619
Immunostics Co., Inc.
Microbiology · 105d
Cleared Nov 18, 1985
ACCESS DIGIWIPE SYSTEM
K853141
Medtech Products, Inc.
Microbiology · 117d
Cleared Jun 17, 1985
EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
K850431
Nms Pharmaceuticals, Inc.
Hematology · 133d
Cleared Jan 04, 1985
ACCESS HEMAWIPE
K843601
Medtech Products, Inc.
Hematology · 114d
Cleared Dec 12, 1984
UROPAPER EIKEN 8
K843532
Syn-Kit, Inc.
Chemistry · 96d
Cleared Dec 05, 1984
COLOSCREEN SELF-TEST
K843352
Helena Laboratories
Hematology · 100d
Cleared Sep 05, 1984
COLOTRAK OCCULT BLOOD TEST
K840527
Breit Laboratories, Inc.
Hematology · 211d