Cleared Traditional

COLON ALERT TEST

K992759 · Immunostics Inc., · Hematology
Dec 1999
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K992759 is an FDA 510(k) clearance for the COLON ALERT TEST, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on December 6, 1999, 111 days after receiving the submission on August 17, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K992759 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 1999
Decision Date December 06, 1999
Days to Decision 111 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

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

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