510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110309Substantially Equivalent

Fob One Step Rapid Test

Orient Gene Biotech, East Stroudsburg PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110309 is the FDA 510(k) clearance record for FOB ONE STEP RAPID TEST, a class II device, cleared for Orient Gene Biotech on under FDA product code KHE (Reagent, Occult Blood). FDA records list one 510(k) clearance for Orient Gene Biotech. As of , FDA records show no recalls naming K110309.

Clearance record

Decision date
Received
(224 days to decision)
Product code
KHE Reagent, Occult Blood
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
Orient Gene Biotech 150 Cherry Ln. Rd., East Stroudsburg PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KHE

Trailing 12 months

FDA records hold no clearances under product code KHE in the trailing twelve months.

FDA records show no clearances under product code KHE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KHE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260