Cleared Traditional

INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST

K070660 · Alfa Scientific Designs, Inc. · Hematology
Jun 2007
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K070660 is an FDA 510(k) clearance for the INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on June 21, 2007, 104 days after receiving the submission on March 9, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K070660 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2007
Decision Date June 21, 2007
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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