BLOOD PLATELET ASSAY METHOD & APPARATUS— 510(k) K862302

Name: FDA 510(k) clearance K862302
Creator: U.S. Food and Drug Administration
Published: 1986-07-31

Substantially Equivalent

Bellhouse Medical, Inc.

FDA 510(k) clearance K862302 for BLOOD PLATELET ASSAY METHOD & APPARATUS, Substantially Equivalent on 1986-07-31. Applicant: Bellhouse Medical, Inc.. Device class: 2.

Clearance details

Applicant: Bellhouse Medical, Inc.
Product code: Code JOZ
Device class: Class 2
Regulation: 21 CFR 864.5700
Advisory panel: Hematology
Date received: 1986-06-17
Decision date: 1986-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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