RSV Oia

FDA 510(k) K021172 · Thermo Biostar, Inc.

Substantially Equivalent

510(k) numberK021172

Submission

Device name
RSV Oia
Applicant
Thermo Biostar, Inc.
Boulder, CO, US
Received
April 12, 2002
Decision date
September 13, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GOG – Antisera, Cf, Poliovirus 1-3
Device class
Class I (low risk)
Regulation
21 CFR 866.3405
Specialty
Microbiology

Other 510(k)s with product code GOG

510(k)DeviceApplicantDecision
K071101Tru RSVGOG · Traditional Meridian Bioscience, Inc.10/18/2007SE
K853278Polio Type I CF Antigen, & Type II, IIIGOG · Traditional Hillcrest Biologicals11/07/1985SE

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K023947GC OiaLIR · Traditional 04/17/2003SE
K023556Flu Oia A/B Test KitPSZ · Traditional 03/27/2003SE
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Questions and answers

When was RSV Oia cleared by the FDA?

RSV Oia (K021172) received a 510(k) decision of Substantially Equivalent on September 13, 2002, 154 days after the submission was received.

What is the product code of K021172?

The FDA product code is GOG – Antisera, Cf, Poliovirus 1-3, a Class I (low risk) device regulated under 21 CFR 866.3405.