FDA 510(k)

RSV OIA

K-Number: K021172 · 2002-09-13

Decision Date2002-09-13

Product CodeGOG

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

RSV 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 2002-09-13 under 510(k) number K021172. The device is classified under product code GOG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RSV OIA?

RSV OIA is a medical device that received FDA 510(k) clearance on 2002-09-13. The listed applicant is Thermo Biostar, Inc.. The 510(k) number is K021172.

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

RSV OIA received FDA 510(k) clearance on 2002-09-13, under 510(k) number K021172.

Who is the listed applicant for RSV 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 RSV OIA?

The FDA product code for RSV OIA is GOG.

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 K023947GC OIA K023556FLU OIA A/B TEST KIT K023779RSV OIA

Related Devices (Code: GOG)

K071101TRU RSVMeridian Bioscience, Inc.K853278POLIO TYPE I CF ANTIGEN, & TYPE II, IIIHillcrest Biologicals

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.