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510(k) K842137

OCCULT BLOOD TEST by Breit Laboratories, Inc. — Product Code KHE

K842137 is an FDA 510(k) premarket notification submitted by Breit Laboratories, Inc. for the device "OCCULT BLOOD TEST". The FDA issued a decision of Substantially Equivalent on September 5, 1984. The device falls under product code KHE (Reagent, Occult Blood), a Class II device regulated under 21 CFR 864.6550. Breit Laboratories, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1984
Date Received
May 30, 1984
Clearance Type
Traditional
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 Breit Laboratories, Inc.

  • K851099 — IGM RHEUMATOID FACTOR TEST KIT (April 25, 1985)
  • K840527 — COLOTRAK OCCULT BLOOD TEST (September 5, 1984)
  • K832031 — ANTI-N DNA ANTIBODY TEST KIT (August 11, 1983)
  • K831927 — ANTINUCLEAR ANTIBODY TEST KIT (July 18, 1983)

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