FOB ONE STEP RAPID TEST— 510(k) K110309

Substantially Equivalent

Orient Gene Biotech

FDA 510(k) clearance K110309 for FOB ONE STEP RAPID TEST, Substantially Equivalent on 2011-09-14. Applicant: Orient Gene Biotech. Device class: 2.

Clearance details

Applicant: Orient Gene Biotech
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2011-02-02
Decision date: 2011-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHE

K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test2018-02-15
K170548 — InSure ONE2017-10-05
K171484 — hema-screen SPECIFIC Gold2017-06-14
K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test2017-05-14
K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test2017-01-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.