FDA 510(k)

GC OIA

K-Number: K023947 · 2003-04-17

Decision Date2003-04-17

Product CodeLIR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

GC 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 2003-04-17 under 510(k) number K023947. The device is classified under product code LIR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC OIA?

GC OIA is a medical device that received FDA 510(k) clearance on 2003-04-17. The listed applicant is Thermo Biostar, Inc.. The 510(k) number is K023947.

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

GC OIA received FDA 510(k) clearance on 2003-04-17, under 510(k) number K023947.

Who is the listed applicant for GC 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 GC OIA?

The FDA product code for GC OIA is LIR.

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.

K032330CT OIA K023556FLU OIA A/B TEST KIT K023779RSV OIA K021172RSV OIA

Related Devices (Code: LIR)

K882534ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROLAbbott Laboratories K881064HYGEIA GC TESTHygeia Sciences

Official Source

View on FDA Database →

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