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FDA 510(k)

UBIT-IR300 INFRARED SPECTROMETRY SYSTEM

K-Number: K013371 · 2001-12-21

ApplicantOtsuka Pharmaceutical Co., Ltd.
Decision Date2001-12-21
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UBIT-IR300 INFRARED SPECTROMETRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Otsuka Pharmaceutical Co., Ltd.. It received FDA 510(k) clearance on 2001-12-21 under 510(k) number K013371. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UBIT-IR300 INFRARED SPECTROMETRY SYSTEM?

UBIT-IR300 INFRARED SPECTROMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-21. The listed applicant is Otsuka Pharmaceutical Co., Ltd.. The 510(k) number is K013371.

When did UBIT-IR300 INFRARED SPECTROMETRY SYSTEM receive FDA 510(k) clearance?

UBIT-IR300 INFRARED SPECTROMETRY SYSTEM received FDA 510(k) clearance on 2001-12-21, under 510(k) number K013371.

Who is the listed applicant for UBIT-IR300 INFRARED SPECTROMETRY SYSTEM?

The FDA 510(k) record lists Otsuka Pharmaceutical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UBIT-IR300 INFRARED SPECTROMETRY SYSTEM?

The FDA product code for UBIT-IR300 INFRARED SPECTROMETRY SYSTEM is JJQ.

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Other records listing Otsuka Pharmaceutical Co., Ltd. as applicant

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Related Devices (Code: JJQ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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