QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS— 510(k) K844927

Name: FDA 510(k) clearance K844927
Creator: U.S. Food and Drug Administration
Published: 1985-03-22

Substantially Equivalent

Bhp Diagnostix, Inc.

FDA 510(k) clearance K844927 for QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS, Substantially Equivalent on 1985-03-22. Applicant: Bhp Diagnostix, Inc.. Device class: 2.

Clearance details

Applicant: Bhp Diagnostix, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1984-12-19
Decision date: 1985-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

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