Cleared Traditional

BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST

K100817 · Princeton BioMeditech Corp. · Hematology
Jul 2010
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K100817 is an FDA 510(k) clearance for the BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on July 1, 2010, 104 days after receiving the submission on March 19, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K100817 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2010
Decision Date July 01, 2010
Days to Decision 104 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KHE — Reagent, Occult Blood
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6550

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