BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT— 510(k) K861499

Name: FDA 510(k) clearance K861499
Creator: U.S. Food and Drug Administration
Published: 1986-06-20

Substantially Equivalent

Biostar Medical Products, Inc.

FDA 510(k) clearance K861499 for BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT, Substantially Equivalent on 1986-06-20. Applicant: Biostar Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Biostar Medical Products, Inc.
Product code: Code DAK
Device class: Class 2
Regulation: 21 CFR 866.5240
Advisory panel: Immunology
Date received: 1986-04-23
Decision date: 1986-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

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