POCONE INFRARED SPECTROPHOTOMETER— 510(k) K041148

Name: FDA 510(k) clearance K041148
Creator: U.S. Food and Drug Administration
Published: 2004-07-15

Substantially Equivalent

Otsuka Pharmaceutical Co., Ltd.

FDA 510(k) clearance K041148 for POCONE INFRARED SPECTROPHOTOMETER, Substantially Equivalent on 2004-07-15. Applicant: Otsuka Pharmaceutical Co., Ltd.. Device class: 1.

Clearance details

Applicant: Otsuka Pharmaceutical Co., Ltd.
Product code: Code MSQ
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 2004-05-03
Decision date: 2004-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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