RSV OIA— 510(k) K021172

Substantially Equivalent

Thermo Biostar, Inc.

FDA 510(k) clearance K021172 for RSV OIA, Substantially Equivalent on 2002-09-13. Applicant: Thermo Biostar, Inc.. Device class: 1.

Clearance details

Applicant: Thermo Biostar, Inc.
Product code: Code GOG
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 2002-04-12
Decision date: 2002-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GOG

K071101 — TRU RSV2007-10-18
K853278 — POLIO TYPE I CF ANTIGEN, & TYPE II, III1985-11-07

More clearances from Thermo Biostar, Inc.

K032330 — CT OIA2004-03-02
K023947 — GC OIA2003-04-17
K023556 — FLU OIA A/B TEST KIT2003-03-27
K023779 — RSV OIA2003-01-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.