510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991829Substantially Equivalent

Cdtox a Oia

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

K991829 is the FDA 510(k) clearance record for CDTOX A OIA, a class I device, cleared for Biostar, Inc. on under FDA product code LLH (Reagents, Clostridium Difficile Toxin). FDA records list 6 510(k) clearances for Biostar, Inc., from to . As of , FDA records show no recalls naming K991829.

Clearance record

Decision date
Received
(158 days to decision)
Product code
LLH Reagents, Clostridium Difficile Toxin
Regulation
21 CFR 866.2660
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 LLH

Trailing 12 months

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

FDA records show no clearances under product code LLH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LLH, 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