Panels › Hematology › Product code KHE · Class 2
Reagent, Occult Blood
Regulation 864.6550
0510(k)s in 12 months (97 all time)
2recalls in 12 months (19 all time)
16recalls that name a 510(k)
Top companies in KHE
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 12 | 2 |
| Immunostics Co., Inc. | 7 | 0 |
| Alere North Americal | 0 | 6 |
| Enterix, Inc. | 3 | 3 |
| Smithkline Diagnostics, Inc. | 4 | 0 |
| Aerscher Diagnostics | 3 | 0 |
| Alfa Scientific Designs, Inc. | 3 | 0 |
| Polymedco, Inc. | 1 | 2 |
| Propper Mfg. Co., Inc. | 3 | 0 |
| Ameritek USA, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 15, 2018 | K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test Alfa Scientific Designs, Inc. | KHE |
| Oct 5, 2017 | K170548 | InSure ONE Enterix, Inc. | KHE |
| Jun 14, 2017 | K171484 | hema-screen SPECIFIC Gold Immunostics Inc., | KHE |
| May 14, 2017 | K162333 | Wondfo One Step Fecal Occult Blood (FOB) Test Guangzhou Wondfo Biotech Co., Ltd., CN | KHE |
| Jan 17, 2017 | K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test Immunostics Inc., | KHE |
| Aug 20, 2015 | K143325 | OC-Light S FIT Eiken Chemical Co., Ltd., JP | KHE |
| Dec 28, 2012 | K121397 | OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT SEKISUI Diagnostics, LLC | KHE |
| Dec 19, 2012 | K113506 | IND ONE STEP OCCULT BLOOD (FOB) TEST Ind Diagnostics, Inc., CA | KHE |
| Sep 14, 2011 | K110309 | FOB ONE STEP RAPID TEST Orient Gene Biotech | KHE |
| Jan 28, 2011 | K102664 | HEMA SCREEN ER Immunostics Inc., | KHE |
| Jul 19, 2010 | K100031 | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 Ind Diagnostic, Inc., CA | KHE |
| Jul 1, 2010 | K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST Princeton BioMeditech Corp. | KHE |
| Jun 25, 2008 | K080812 | HEMOCCULT ICT Beckman Coulter, Inc. | KHE |
| Mar 6, 2008 | K071242 | DBEST ONE STEP OCCULT BLOOD TEST KITS Ameritek USA, Inc. | KHE |
| Jan 14, 2008 | K073431 | FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T Tianjin New Bay Bioresearch Co., Ltd. | KHE |
| Jun 21, 2007 | K070660 | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST Alfa Scientific Designs, Inc. | KHE |
| May 11, 2007 | K063693 | FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST New Bay Bioresearch Co. , Ltd. | KHE |
| Mar 5, 2007 | K063673 | INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE Innovacon, Inc. | KHE |
| Sep 18, 2006 | K060953 | OCCULTECH FECAL OCCULT BLOOD RAPID TEST Yd Diagnostics Corp. | KHE |
| Jul 14, 2006 | K061065 | FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 Teco Diagnostics | KHE |
| Jun 6, 2006 | K060463 | HEMA SCREEN SPECIFIC IFOBT Immunostics Inc., | KHE |
| May 4, 2006 | K060930 | INSURE II Enterix, Inc. | KHE |
| Mar 16, 2006 | K052598 | IMMOCARE Care Diagnostic, Inc. | KHE |
| Oct 3, 2005 | K051806 | CARE FECAL OCCULT BLOOD TEST, MODEL KT313 Epitope Diagnostics, Inc. | KHE |
| Aug 12, 2004 | K041297 | POLYMEDCO OC LIGHT FOBT TEST Polymedco, Inc. | KHE |
| Aug 12, 2004 | K041202 | HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST W.H.P.M., Inc. | KHE |
| Nov 24, 2003 | K033548 | ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER Roche Diagnostics Corp. | KHE |
| Sep 24, 2003 | K031356 | HEMAPROMPT GASTRIC Aerscher Diagnostics | KHE |
| Apr 2, 2003 | K030216 | COLONCARE Care Products, Inc. | KHE |
| Sep 24, 2002 | K022755 | LIFEGUARD Medtek, LLC | KHE |
| Jun 17, 2002 | K021423 | INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST Alfa Scientific Designs, Inc. | KHE |
| Feb 23, 2001 | K002756 | EASE-A-CULT Diagnostica, Inc. | KHE |
| Jan 22, 2001 | K002930 | INSTACCULT Medtek Diagnostics, LLC | KHE |
| Jan 12, 2001 | K002457 | !NSURE FECAL OCCULT BLOOD TEST Enterix, Inc. | KHE |
| Nov 27, 2000 | K003359 | COLOSCREEN-ES Helena Laboratories | KHE |
| Dec 6, 1999 | K992759 | COLON ALERT TEST Immunostics Inc., | KHE |
| May 11, 1999 | K984269 | DBEST OCCULT BLOOD TEST KIT Ameritek, Inc. | KHE |
| Sep 15, 1998 | K981661 | HEMAPROMPT Aerscher Diagnostics | KHE |
| May 12, 1998 | K980671 | COLOSCREEN-ES Helena Laboratories | KHE |
| Oct 20, 1997 | K972763 | HEMAPROMPT Aerscher Diagnostics | KHE |
| Nov 6, 1996 | K961062 | FLEXSURE OBT Smithkline Diagnostics, Inc. | KHE |
| Apr 5, 1995 | K936056 | HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES Dipro Diagnostic Products GmbH | KHE |
| Oct 5, 1992 | K921798 | PROPPER SUPER SERACULT(R) Propper Mfg. Co., Inc. | KHE |
| Jan 31, 1992 | K913622 | HEMOPLUS Sarstedt, Inc. | KHE |
| Oct 4, 1991 | K912979 | HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION Labeltape Meditect, Inc. | KHE |
| Jul 3, 1991 | K911075 | COLOSCREEN Helena Laboratories | KHE |
| Jul 3, 1991 | K905798 | COLOCARE Helena Laboratories | KHE |
| May 6, 1991 | K905782 | FHT (FECAL HEME TEST) Aerscher, Inc. | KHE |
| Nov 5, 1990 | K901064 | MONOHAEM (FECAL OCCULT BLOOD TEST) Silenus Laboratories Proprietary , Ltd. | KHE |
| Jul 27, 1990 | K902360 | HEMA-SCREEN Immunostics Co., Inc. | KHE |
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