STREP A OIA MAX— 510(k) K962060

Substantially Equivalent

Biostar, Inc.

FDA 510(k) clearance K962060 for STREP A OIA MAX, Substantially Equivalent on 1997-07-23. Applicant: Biostar, Inc.. Device class: 1.

Clearance details

Applicant
Biostar, Inc.
Product code
Code GTZ
Device class
Class 1
Regulation
21 CFR 866.3740
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boulder, CO, US
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