KHE · Class II · 21 CFR 864.6550

FDA Product Code KHE: Reagent, Occult Blood

Leading manufacturers include Helena Laboratories, Smithkline Diagnostics, Inc. and Propper Mfg. Co., Inc..

97
Total
97
Cleared
135d
Avg days
1976
Since
97 devices
25–48 of 97
Cleared Nov 06, 1996
FLEXSURE OBT
K961062
Smithkline Diagnostics, Inc.
Hematology · 233d
Cleared Oct 05, 1992
PROPPER SUPER SERACULT(R)
K921798
Propper Mfg. Co., Inc.
Hematology · 174d
Cleared Oct 04, 1991
HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
K912979
Labeltape Meditect, Inc.
Hematology · 123d
Cleared Jul 03, 1991
COLOCARE
K905798
Helena Laboratories
Hematology · 226d
Cleared Jul 03, 1991
COLOSCREEN
K911075
Helena Laboratories
Hematology · 114d
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
HELENA COLOCARE
K882799
Helena Laboratories
Hematology · 86d
Cleared Jul 08, 1988
IMMUNOCCULT EIA TEST KIT
K871143
Intl. Immunoassay Laboratories, Inc.
Hematology · 473d
Cleared May 23, 1988
HEMOCCULT SENSITIVE TEST
K880499
Smithkline Diagnostics, Inc.
Hematology · 108d
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 May 06, 1986
BIOTEL (TM)/ KIDNEY
K855237
American Diagnostic Corp.
Hematology · 126d
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 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 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 Oct 08, 1982
GASTROCCULT TM
K821884
Smithkline Diagnostics, Inc.
Hematology · 105d
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