Cleared Traditional

POCONE INFRARED SPECTROPHOTOMETER

K041148 · Otsuka Pharmaceutical Co., Ltd. · Microbiology
Jul 2004
Decision
73d
Days
Class 1
Risk

About This 510(k) Submission

K041148 is an FDA 510(k) clearance for the POCONE INFRARED SPECTROPHOTOMETER, 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 July 15, 2004, 73 days after receiving the submission on May 3, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K041148 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2004
Decision Date July 15, 2004
Days to Decision 73 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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