Cleared Traditional

HEMA SCREEN SPECIFIC IFOBT

K060463 · Immunostics Inc., · Hematology
Jun 2006
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K060463 is an FDA 510(k) clearance for the HEMA SCREEN SPECIFIC IFOBT, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on June 6, 2006, 104 days after receiving the submission on February 22, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K060463 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2006
Decision Date June 06, 2006
Days to Decision 104 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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