Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- GKGCentrifuge, Hematocrit2Product Code
- GKMHand-Tally, Differential1Product Code
- GJGPipette, Quantitative, Hematology1Product Code
- GJWPipette, Pasteur1Product Code
- GKEOsmotic Fragility Testing1Product Code
- GGGGuaiac Reagent2Product Code
- GGXPipette, Sahli1Product Code
- GGYPipette, Diluting1Product Code
- GHCTube, Sedimentation Rate1Product Code
- GHOHemocytometer1Product Code
- GHYHematocrit, Tube, Rack, Sealer, Holder2Product Code
- GIOTube, Collection, Capillary Blood1Product Code
- GKWAggregometer, Platelet, Thrombokinetogram2Product Code
- GLGPlatelet Counting, Manual1Product Code
- JBXAggregrometer, Platelet2Product Code
- JBYAggregometer, Platelet, Photo-Optical Scanning2Product Code
- JBZStudy, Platelet Adhesive2Product Code
- JCADevice, Bleeding Time2Product Code
- JIOBlood, Occult, Colorimetric, In Urine2Product Code
- JIPBlood, Occult, Enzymatic Method, In Urine2Product Code
- JPHTest, Erythrocyte Sedimentation Rate1Product Code
- JPIDevice, Hematocrit Measuring2Product Code
- KHEReagent, Occult Blood2Product Code
- K173212Instant-view-PLUS immunochemical Fecal Occult Blood Test2Cleared 510(K)
- K170548InSure ONE2Cleared 510(K)
- K171484hema-screen SPECIFIC Gold2Cleared 510(K)
- K162333Wondfo One Step Fecal Occult Blood (FOB) Test2Cleared 510(K)
- K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test2Cleared 510(K)
- K143325OC-Light S FIT2Cleared 510(K)
- K121397OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT2Cleared 510(K)
- K113506IND ONE STEP OCCULT BLOOD (FOB) TEST2Cleared 510(K)
- K110309FOB ONE STEP RAPID TEST2Cleared 510(K)
- K102664HEMA SCREEN ER2Cleared 510(K)
- K100031IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-102Cleared 510(K)
- K100817BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST2Cleared 510(K)
- K080812HEMOCCULT ICT2Cleared 510(K)
- K071242DBEST ONE STEP OCCULT BLOOD TEST KITS2Cleared 510(K)
- K073431FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T2Cleared 510(K)
- K070660INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST2Cleared 510(K)
- K063693FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST2Cleared 510(K)
- K063673INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE2Cleared 510(K)
- K060953OCCULTECH FECAL OCCULT BLOOD RAPID TEST2Cleared 510(K)
- K061065FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-252Cleared 510(K)
- K060463HEMA SCREEN SPECIFIC IFOBT2Cleared 510(K)
- K060930INSURE II2Cleared 510(K)
- K052598IMMOCARE2Cleared 510(K)
- K051806CARE FECAL OCCULT BLOOD TEST, MODEL KT3132Cleared 510(K)
- K041297POLYMEDCO OC LIGHT FOBT TEST2Cleared 510(K)
- K041202HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST2Cleared 510(K)
- K033548ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER2Cleared 510(K)
- K031356HEMAPROMPT GASTRIC2Cleared 510(K)
- K030216COLONCARE2Cleared 510(K)
- K022755LIFEGUARD2Cleared 510(K)
- K021423INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST2Cleared 510(K)
- K002756EASE-A-CULT2Cleared 510(K)
- K002930INSTACCULT2Cleared 510(K)
- K002457!NSURE FECAL OCCULT BLOOD TEST2Cleared 510(K)
- K003359COLOSCREEN-ES2Cleared 510(K)
- K992759COLON ALERT TEST2Cleared 510(K)
- K984269DBEST OCCULT BLOOD TEST KIT2Cleared 510(K)
- K981661HEMAPROMPT2Cleared 510(K)
- K980671COLOSCREEN-ES2Cleared 510(K)
- K972763HEMAPROMPT2Cleared 510(K)
- K961062FLEXSURE OBT2Cleared 510(K)
- K936056HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES2Cleared 510(K)
- K921798PROPPER SUPER SERACULT(R)2Cleared 510(K)
- K913622HEMOPLUS2Cleared 510(K)
- K912979HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION2Cleared 510(K)
- K911075COLOSCREEN2Cleared 510(K)
- K905798COLOCARE2Cleared 510(K)
- K905782FHT (FECAL HEME TEST)2Cleared 510(K)
- K901064MONOHAEM (FECAL OCCULT BLOOD TEST)2Cleared 510(K)
- K902360HEMA-SCREEN2Cleared 510(K)
- K896474RESUBMITTED FECATWIN SENSITIVE - FECA-EIA2Cleared 510(K)
- K884206HEMAWIPE SYSTEM, THE CIVILIZED TEST2Cleared 510(K)
- K883432IMMUNOCCULT-LXI2Cleared 510(K)
- K882799HELENA COLOCARE2Cleared 510(K)
- K874180COLORECTAL CANCER RISK DETECTOR (TM)2Cleared 510(K)
- K881907HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD2Cleared 510(K)
- K871143IMMUNOCCULT EIA TEST KIT2Cleared 510(K)
- K880499HEMOCCULT SENSITIVE TEST2Cleared 510(K)
- K874482REVISED IMMUDIA HEM-SP2Cleared 510(K)
- K873409WAKO(TM) PRETEST 6A2Cleared 510(K)
- K862849HEMOCCULT WIPE TEST2Cleared 510(K)
- K861731NATURAL DETECTOR SYSTEM2Cleared 510(K)
- K855237BIOTEL (TM)/ KIDNEY2Cleared 510(K)
- K854358EZ DETECH-URINE BLOOD TEST STICKS2Cleared 510(K)
- K860028MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL2Cleared 510(K)
- K854619DETECTACULT2Cleared 510(K)
- K853141ACCESS DIGIWIPE SYSTEM2Cleared 510(K)
- K850431EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL2Cleared 510(K)
- K843601ACCESS HEMAWIPE2Cleared 510(K)
- K843532UROPAPER EIKEN 82Cleared 510(K)
- K843352COLOSCREEN SELF-TEST2Cleared 510(K)
- K842137OCCULT BLOOD TEST2Cleared 510(K)
- K840527COLOTRAK OCCULT BLOOD TEST2Cleared 510(K)
- K840904ACCU-CULT FECAL OCCULT BLOOD TEST2Cleared 510(K)
- K840903HELENA COLOSCREEN SELF-TEST2Cleared 510(K)
- K833369EARLY DETECTOR2Cleared 510(K)
- K832311HEMOCCULT-C2Cleared 510(K)
- K834297PROPPER SERACULT2Cleared 510(K)
- K834456HELENA BIO STRIP OB2Cleared 510(K)
- K832864COLOSCREEN V.P.I.2Cleared 510(K)
- K830919OCCULT-ALERT2Cleared 510(K)
- K830223FECAL OCCULT SLIDE TEST KIT2Cleared 510(K)
- K822731HEMOTECT2Cleared 510(K)
- K821884GASTROCCULT TM2Cleared 510(K)
- K812728FLEET DETECTATEST2Cleared 510(K)
- K820072FE-CULT PLUS2Cleared 510(K)
- K813204SERACULT OCCULT BLOOF TEST2Cleared 510(K)
- K811815UROPAPER EIKEG2Cleared 510(K)
- K811752FE-CULT PLUS2Cleared 510(K)
- K812428HELENA COLOSCREEN METHOD2Cleared 510(K)
- K810488HOME HEALTH CHEKUP KIT2Cleared 510(K)
- K800433HELENA COLOCHECK2Cleared 510(K)
- K792655HELENA COLOSCREEN2Cleared 510(K)
- K780564FECATEST2Cleared 510(K)
- K780214HEMO FEC2Cleared 510(K)
- K770153CAMCO R PAK-GUAIAC2Cleared 510(K)
- K761232QUICK CULT SLIDE TEST FECAL OCCULT BLOOD2Cleared 510(K)
- OOXAutomated Occult Blood Analyzer2Product Code
- OSLControl, Fecal Occult Blood2Product Code
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
HELENA COLOSCREEN METHOD
- Page Type
- Cleared 510(K)
- 510(k) Number
- K812428
- 510(k) Type
- Traditional
- Applicant
- HELENA LABORATORIES
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/23/1981
- Days to Decision
- 59 days