Product code KHE— Hematology
COLOSCREEN-ES
- Classification name
- Reagent, Occult Blood
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Total cleared
- 97
- First cleared
- Most recent
Market context for product code KHE
FDA has cleared devices under product code KHE between 1976 and 2018, filed by 62 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2018
- 2017
- 2015
- 2012
- 2011
- 2010
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
Top applicants under product code KHE
Recent clearances under product code KHE
- K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test
- K170548 — InSure ONE
- K171484 — hema-screen SPECIFIC Gold
- K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test
- K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
- K143325 — OC-Light S FIT
- K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
- K113506 — IND ONE STEP OCCULT BLOOD (FOB) TEST
- K110309 — FOB ONE STEP RAPID TEST
- K102664 — HEMA SCREEN ER
- K100031 — IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
- K100817 — BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
- K080812 — HEMOCCULT ICT
- K071242 — DBEST ONE STEP OCCULT BLOOD TEST KITS
- K073431 — FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T
- K070660 — INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
- K063693 — FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST
- K063673 — INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE
- K060953 — OCCULTECH FECAL OCCULT BLOOD RAPID TEST
- K061065 — FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
- K060463 — HEMA SCREEN SPECIFIC IFOBT
- K060930 — INSURE II
- K052598 — IMMOCARE
- K051806 — CARE FECAL OCCULT BLOOD TEST, MODEL KT313
- K041202 — HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
- K041297 — POLYMEDCO OC LIGHT FOBT TEST
- K033548 — ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
- K031356 — HEMAPROMPT GASTRIC
- K030216 — COLONCARE
- K022755 — LIFEGUARD
- K021423 — INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
- K002756 — EASE-A-CULT
- K002930 — INSTACCULT
- K002457 — !NSURE FECAL OCCULT BLOOD TEST
- K003359 — COLOSCREEN-ES
- K992759 — COLON ALERT TEST
- K984269 — DBEST OCCULT BLOOD TEST KIT
- K981661 — HEMAPROMPT
- K980671 — COLOSCREEN-ES
- K972763 — HEMAPROMPT
- K961062 — FLEXSURE OBT
- K936056 — HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES
- K921798 — PROPPER SUPER SERACULT(R)
- K913622 — HEMOPLUS
- K912979 — HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
- K905798 — COLOCARE
- K911075 — COLOSCREEN
- K905782 — FHT (FECAL HEME TEST)
- K901064 — MONOHAEM (FECAL OCCULT BLOOD TEST)
- K902360 — HEMA-SCREEN
- K896474 — RESUBMITTED FECATWIN SENSITIVE - FECA-EIA
- K884206 — HEMAWIPE SYSTEM, THE CIVILIZED TEST
- K883432 — IMMUNOCCULT-LXI
- K874180 — COLORECTAL CANCER RISK DETECTOR (TM)
- K882799 — HELENA COLOCARE
- K871143 — IMMUNOCCULT EIA TEST KIT
- K881907 — HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD
- K880499 — HEMOCCULT SENSITIVE TEST
- K874482 — REVISED IMMUDIA HEM-SP
- K873409 — WAKO(TM) PRETEST 6A
- K862849 — HEMOCCULT WIPE TEST
- K861731 — NATURAL DETECTOR SYSTEM
- K855237 — BIOTEL (TM)/ KIDNEY
- K854358 — EZ DETECH-URINE BLOOD TEST STICKS
- K860028 — MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL
- K854619 — DETECTACULT
- K853141 — ACCESS DIGIWIPE SYSTEM
- K850431 — EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
- K843601 — ACCESS HEMAWIPE
- K843532 — UROPAPER EIKEN 8
- K843352 — COLOSCREEN SELF-TEST
- K840527 — COLOTRAK OCCULT BLOOD TEST
- K842137 — OCCULT BLOOD TEST
- K840904 — ACCU-CULT FECAL OCCULT BLOOD TEST
- K840903 — HELENA COLOSCREEN SELF-TEST
- K833369 — EARLY DETECTOR
- K832311 — HEMOCCULT-C
- K834297 — PROPPER SERACULT
- K834456 — HELENA BIO STRIP OB
- K832864 — COLOSCREEN V.P.I.
- K830919 — OCCULT-ALERT
- K830223 — FECAL OCCULT SLIDE TEST KIT
- K822731 — HEMOTECT
- K821884 — GASTROCCULT TM
- K812728 — FLEET DETECTATEST
- K820072 — FE-CULT PLUS
- K813204 — SERACULT OCCULT BLOOF TEST
- K811815 — UROPAPER EIKEG
- K811752 — FE-CULT PLUS
- K812428 — HELENA COLOSCREEN METHOD
- K810488 — HOME HEALTH CHEKUP KIT
- K800433 — HELENA COLOCHECK
- K792655 — HELENA COLOSCREEN
- K780564 — FECATEST
- K780214 — HEMO FEC
- K770153 — CAMCO R PAK-GUAIAC
- K761232 — QUICK CULT SLIDE TEST FECAL OCCULT BLOOD
Data sourced from openFDA. This site is unofficial and independent of the FDA.