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
25–48 of 97
Cleared Aug 12, 2004
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
K041202
W.H.P.M., Inc.
Hematology · 97d
Cleared Aug 12, 2004
POLYMEDCO OC LIGHT FOBT TEST
K041297
Polymedco, Inc.
Hematology · 90d
Cleared Nov 24, 2003
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548
Roche Diagnostics Corp.
Chemistry · 12d
Cleared Sep 24, 2003
HEMAPROMPT GASTRIC
K031356
Aerscher Diagnostics
Hematology · 166d
Cleared Apr 02, 2003
COLONCARE
K030216
Care Products, Inc.
Hematology · 71d
Cleared Sep 24, 2002
LIFEGUARD
K022755
Medtek, LLC
Hematology · 35d
Cleared Jun 17, 2002
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
K021423
Alfa Scientific Designs, Inc.
Hematology · 45d
Cleared Feb 23, 2001
EASE-A-CULT
K002756
Diagnostica, Inc.
Hematology · 171d
Cleared Jan 22, 2001
INSTACCULT
K002930
Medtek Diagnostics, LLC
Hematology · 124d
Cleared Jan 12, 2001
!NSURE FECAL OCCULT BLOOD TEST
K002457
Enterix, Inc.
Hematology · 155d
Cleared Nov 27, 2000
COLOSCREEN-ES
K003359
Helena Laboratories
Hematology · 31d
Cleared Dec 06, 1999
COLON ALERT TEST
K992759
Immunostics Inc.,
Hematology · 111d
Cleared May 11, 1999
DBEST OCCULT BLOOD TEST KIT
K984269
Ameritek, Inc.
Hematology · 201d
Cleared Sep 15, 1998
HEMAPROMPT
K981661
Aerscher Diagnostics
Hematology · 132d
Cleared May 12, 1998
COLOSCREEN-ES
K980671
Helena Laboratories
Hematology · 81d
Cleared Oct 20, 1997
HEMAPROMPT
K972763
Aerscher Diagnostics
Hematology · 88d
Cleared Nov 06, 1996
FLEXSURE OBT
K961062
Smithkline Diagnostics, Inc.
Hematology · 233d
Cleared Apr 05, 1995
HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES
K936056
Dipro Diagnostic Products GmbH
Hematology · 471d
Cleared Oct 05, 1992
PROPPER SUPER SERACULT(R)
K921798
Propper Mfg. Co., Inc.
Hematology · 174d
Cleared Jan 31, 1992
HEMOPLUS
K913622
Sarstedt, Inc.
Hematology · 170d
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 May 06, 1991
FHT (FECAL HEME TEST)
K905782
Aerscher, Inc.
Hematology · 136d