Cleared Traditional

POC-AS10 AUTO SAMPLER

K092817 · Otsuka Pharmaceutical Co., Ltd. · Microbiology
Mar 2010
Decision
176d
Days
Class 1
Risk

About This 510(k) Submission

K092817 is an FDA 510(k) clearance for the POC-AS10 AUTO SAMPLER, a Test, Urea (breath Or Blood) (Class I — General Controls, product code MSQ), submitted by Otsuka Pharmaceutical Co., Ltd. (North Attleboro, US). The FDA issued a Cleared decision on March 9, 2010, 176 days after receiving the submission on September 14, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K092817 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2009
Decision Date March 09, 2010
Days to Decision 176 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MSQ — Test, Urea (breath Or Blood)
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3110

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