FDA 510(k)

CT OIA

K-Number: K032330 · 2004-03-02

Decision Date2004-03-02

Product CodeLJC

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

CT OIA is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Biostar, Inc.. It received FDA 510(k) clearance on 2004-03-02 under 510(k) number K032330. The device is classified under product code LJC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT OIA?

CT OIA is a medical device that received FDA 510(k) clearance on 2004-03-02. The listed applicant is Thermo Biostar, Inc.. The 510(k) number is K032330.

When did CT OIA receive FDA 510(k) clearance?

CT OIA received FDA 510(k) clearance on 2004-03-02, under 510(k) number K032330.

Who is the listed applicant for CT OIA?

The FDA 510(k) record lists Thermo Biostar, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT OIA?

The FDA product code for CT OIA is LJC.

Other records listing Thermo Biostar, Inc. 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.

K023947GC OIA K023556FLU OIA A/B TEST KIT K023779RSV OIA K021172RSV OIA

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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.