HBA SPERM-HYALURONAN BINDING ASSAY— 510(k) K032874

Name: FDA 510(k) clearance K032874
Creator: U.S. Food and Drug Administration
Published: 2003-11-24

Substantially Equivalent

Biocoat, Inc.

FDA 510(k) clearance K032874 for HBA SPERM-HYALURONAN BINDING ASSAY, Substantially Equivalent on 2003-11-24. Applicant: Biocoat, Inc.. Device class: 2.

Clearance details

Applicant: Biocoat, Inc.
Product code: Code POV
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2003-09-15
Decision date: 2003-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Washington, PA, US

Download summary PDF View on FDA.gov ↗

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