510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K060953Substantially Equivalent

Occultech Fecal Occult Blood Rapid Test

YD Diagnostics, Annandale VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060953 is the FDA 510(k) clearance record for OCCULTECH FECAL OCCULT BLOOD RAPID TEST, a class II device, cleared for Yd Diagnostics Corp. on under FDA product code KHE (Reagent, Occult Blood). FDA records list 5 510(k) clearances for Yd Diagnostics Corp., from to . As of , FDA records show no recalls naming K060953.

Clearance record

Decision date
Received
(165 days to decision)
Product code
KHE Reagent, Occult Blood
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
Yd Diagnostics Corp. 4304 Evergreen Ln., Annandale VA
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