Cleared Traditional

UBIT-IR300 INFRARED SPECTROMETRY SYSTEM

K013371 · Otsuka Pharmaceutical Co., Ltd. · Microbiology
Dec 2001
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K013371 is an FDA 510(k) clearance for the UBIT-IR300 INFRARED SPECTROMETRY SYSTEM, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Otsuka Pharmaceutical Co., Ltd. (North Attleboro, US). The FDA issued a Cleared decision on December 21, 2001, 71 days after receiving the submission on October 11, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K013371 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 2001
Decision Date December 21, 2001
Days to Decision 71 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2300

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