UBIT-IR300 INFRARED SPECTROMETRY SYSTEM— 510(k) K013371

Name: FDA 510(k) clearance K013371
Creator: U.S. Food and Drug Administration
Published: 2001-12-21

Substantially Equivalent

Otsuka Pharmaceutical Co., Ltd.

FDA 510(k) clearance K013371 for UBIT-IR300 INFRARED SPECTROMETRY SYSTEM, Substantially Equivalent on 2001-12-21. Applicant: Otsuka Pharmaceutical Co., Ltd.. Device class: 1.

Clearance details

Applicant: Otsuka Pharmaceutical Co., Ltd.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 2001-10-11
Decision date: 2001-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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