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FDA 510(k)

POCONE INFRARED SPECTROPHOTOMETER

K-Number: K041148 · 2004-07-15

ApplicantOtsuka Pharmaceutical Co., Ltd.
Decision Date2004-07-15
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

POCONE INFRARED SPECTROPHOTOMETER 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 2004-07-15 under 510(k) number K041148. The device is classified under product code MSQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POCONE INFRARED SPECTROPHOTOMETER?

POCONE INFRARED SPECTROPHOTOMETER is a medical device that received FDA 510(k) clearance on 2004-07-15. The listed applicant is Otsuka Pharmaceutical Co., Ltd.. The 510(k) number is K041148.

When did POCONE INFRARED SPECTROPHOTOMETER receive FDA 510(k) clearance?

POCONE INFRARED SPECTROPHOTOMETER received FDA 510(k) clearance on 2004-07-15, under 510(k) number K041148.

Who is the listed applicant for POCONE INFRARED SPECTROPHOTOMETER?

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 POCONE INFRARED SPECTROPHOTOMETER?

The FDA product code for POCONE INFRARED SPECTROPHOTOMETER is MSQ.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K092817POC-AS10 AUTO SAMPLERK052716RAPIRUN H. PYLORI ANTIBODY DETECTION KITK013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMK001032RLP-CHOLESTEROL IMMUNOSEPARATION ASSAYK991083RLP CHOLESTEROL IMMUNOSEPARATION ASSAY

Related Devices (Code: MSQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221896BreathID Hp SystemMeridian Bioscience Israel , Ltd.K223185BreathID® Smart SystemMeridian Bioscience Israel , Ltd.K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel , Ltd.K193610BreathID Smart SystemExalenz Bioscience , Ltd.K173772BreathID Hp SystemExalenz Bioscience , Ltd.K173777BreathID Hp Lab SystemExalenz Bioscience , Ltd.

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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