510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991828Substantially Equivalent

Strep B Oia

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

K991828 is the FDA 510(k) clearance record for STREP B OIA, a class I device, cleared for Biostar, Inc. on under FDA product code GTY (Antigens, All Groups, Streptococcus Spp.). FDA records list 6 510(k) clearances for Biostar, Inc., from to . As of , FDA records show no recalls naming K991828.

Clearance record

Decision date
Received
(83 days to decision)
Product code
GTY Antigens, All Groups, Streptococcus Spp.
Regulation
21 CFR 866.3740
Device class
Class I
Review panel
Microbiology
Applicant
Biostar, Inc. 6655 Lookout Rd., Boulder CO
510(k) summary
Summary
Third party review
No

Clearances, product code GTY

Trailing 12 months
2 clearances under product code GTY in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GTY, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260