PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS— 510(k) K860586

Name: FDA 510(k) clearance K860586
Creator: U.S. Food and Drug Administration
Published: 1986-05-07

Substantially Equivalent

Diagnostic Technology, Inc.

FDA 510(k) clearance K860586 for PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS, Substantially Equivalent on 1986-05-07. Applicant: Diagnostic Technology, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Technology, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1986-02-19
Decision date: 1986-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

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