510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K021172Substantially Equivalent

Rsv Oia

Thermo Biostar, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021172 is the FDA 510(k) clearance record for RSV OIA, a class I device, cleared for Thermo Biostar, Inc. on under FDA product code GOG (Antisera, Cf, Poliovirus 1-3). FDA records list 5 510(k) clearances for Thermo Biostar, Inc., from to . As of , FDA records show no recalls naming K021172.

Clearance record

Decision date
Received
(154 days to decision)
Product code
GOG Antisera, Cf, Poliovirus 1-3
Regulation
21 CFR 866.3405
Device class
Class I
Review panel
Microbiology
Applicant
Thermo Biostar, Inc. 6655 Lookout Rd., Boulder CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GOG

Trailing 12 months

FDA records hold no clearances under product code GOG in the trailing twelve months.

FDA records show no clearances under product code GOG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GOG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260