Cleared Traditional

K080094 - OLYMPUS TOTAL BHCG TEST SYSTEN
(FDA 510(k) Clearance)

K080094 · Olympus Life Science Research Europa GmbH (Europa) · Chemistry
Sep 2008
Decision
233d
Days
Class 2
Risk

K080094 is an FDA 510(k) clearance for the OLYMPUS TOTAL BHCG TEST SYSTEN. This device is classified as a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA).

Submitted by Olympus Life Science Research Europa GmbH (Europa) (Irving, US). The FDA issued a Cleared decision on September 3, 2008, 233 days after receiving the submission on January 14, 2008.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K080094 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2008
Decision Date September 03, 2008
Days to Decision 233 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code DHA — System, Test, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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