CDTOX A OIA— 510(k) K991829

Substantially Equivalent

Biostar, Inc.

FDA 510(k) clearance K991829 for CDTOX A OIA, Substantially Equivalent on 1999-11-02. Applicant: Biostar, Inc.. Device class: 1.

Clearance details

Applicant: Biostar, Inc.
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1999-05-28
Decision date: 1999-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

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