TRI-COUNT CALIBRATOR— 510(k) K844708

Name: FDA 510(k) clearance K844708
Creator: U.S. Food and Drug Administration
Published: 1985-03-05

Substantially Equivalent

Hematology Marketing Assoc.

FDA 510(k) clearance K844708 for TRI-COUNT CALIBRATOR, Substantially Equivalent on 1985-03-05. Applicant: Hematology Marketing Assoc.. Device class: 2.

Clearance details

Applicant: Hematology Marketing Assoc.
Product code: Code KSA
Device class: Class 2
Regulation: 21 CFR 864.8185
Advisory panel: Hematology
Date received: 1984-12-03
Decision date: 1985-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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