SERIES 810 PLATELET ANALYZER— 510(k) K803128

Name: FDA 510(k) clearance K803128
Creator: U.S. Food and Drug Administration
Published: 1981-04-03

Substantially Equivalent

J.T. Baker Chemical Co.

FDA 510(k) clearance K803128 for SERIES 810 PLATELET ANALYZER, Substantially Equivalent on 1981-04-03. Applicant: J.T. Baker Chemical Co.. Device class: 2.

Clearance details

Applicant: J.T. Baker Chemical Co.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1980-12-12
Decision date: 1981-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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