Cleared Special

hema-screen SPECIFIC Gold

K171484 · Immunostics Inc., · Hematology
Jun 2017
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K171484 is an FDA 510(k) clearance for the hema-screen SPECIFIC Gold, 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 14, 2017, 23 days after receiving the submission on May 22, 2017. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K171484 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2017
Decision Date June 14, 2017
Days to Decision 23 days
Submission Type Special
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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