510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063693Substantially Equivalent

Forsure One Step Fecal Occult Blood (Fob) Screen Card Test

New Bay Bioresearch Co., Ltd., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063693 is the FDA 510(k) clearance record for FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST, a class II device, cleared for New Bay Bioresearch Co. , Ltd. on under FDA product code KHE (Reagent, Occult Blood). FDA records list one 510(k) clearance for New Bay Bioresearch Co. , Ltd. As of , FDA records show 4 recalls naming K063693.

Clearance record

Decision date
Received
(149 days to decision)
Product code
KHE Reagent, Occult Blood
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
New Bay Bioresearch Co. , Ltd. 3108 Avenida Olmeda, Carlsbad CA
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