Cleared Traditional

OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT

K121397 · SEKISUI Diagnostics, LLC · Hematology
Dec 2012
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K121397 is an FDA 510(k) clearance for the OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by SEKISUI Diagnostics, LLC (San Diegi, US). The FDA issued a Cleared decision on December 28, 2012, 233 days after receiving the submission on May 9, 2012. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K121397 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2012
Decision Date December 28, 2012
Days to Decision 233 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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