Cleared Special

HEMA SCREEN ER

K102664 · Immunostics Inc., · Hematology
Jan 2011
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K102664 is an FDA 510(k) clearance for the HEMA SCREEN ER, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on January 28, 2011, 135 days after receiving the submission on September 15, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K102664 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2010
Decision Date January 28, 2011
Days to Decision 135 days
Submission Type Special
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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