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510(k) K073431

FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T by Tianjin New Bay Bioresearch Co., Ltd. — Product Code KHE

K073431 is an FDA 510(k) premarket notification submitted by Tianjin New Bay Bioresearch Co., Ltd. for the device "FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T". The FDA issued a decision of Substantially Equivalent on January 14, 2008. The device falls under product code KHE (Reagent, Occult Blood), a Class II device regulated under 21 CFR 864.6550. Tianjin New Bay Bioresearch Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2008
Date Received
December 6, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Occult Blood
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

Other clearances by Tianjin New Bay Bioresearch Co., Ltd.

  • K130275 — QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST (September 26, 2013)
  • K122064 — FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE (May 7, 2013)
  • K112449 — QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST (September 24, 2012)
  • K071489 — HOMECHECK MULTIPLE DRUG CUP TEST (March 28, 2008)
  • K061617 — FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST (November 22, 2006)
  • K052520 — RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMIN (April 24, 2006)
  • K052882 — FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE (February 15, 2006)
  • K052208 — GLUCOSE PILOT (December 9, 2005)
  • K042988 — RAPID ONE STEP BUPRENORPHINE TEST CARD (May 12, 2005)
  • K042990 — FOR SURE ONE STEP BUPRENORPHINE TEST STRIP (May 10, 2005)

Other clearances for product code KHE

  • K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test (February 15, 2018)
  • K170548 — InSure ONE (October 5, 2017)
  • K171484 — hema-screen SPECIFIC Gold (June 14, 2017)
  • K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test (May 14, 2017)
  • K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (January 17, 2017)
  • K143325 — OC-Light S FIT (August 20, 2015)
  • K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 (December 28, 2012)
  • K113506 — IND ONE STEP OCCULT BLOOD (FOB) TEST (December 19, 2012)
  • K110309 — FOB ONE STEP RAPID TEST (September 14, 2011)
  • K102664 — HEMA SCREEN ER (January 28, 2011)

FDA data resources