HEMATOLOGY ANALYZER— 510(k) K842310

Name: FDA 510(k) clearance K842310
Creator: U.S. Food and Drug Administration
Published: 1984-09-06

Substantially Equivalent

Hml Inc/Biotechnology Transfer

FDA 510(k) clearance K842310 for HEMATOLOGY ANALYZER, Substantially Equivalent on 1984-09-06. Applicant: Hml Inc/Biotechnology Transfer. Device class: 1.

Clearance details

Applicant: Hml Inc/Biotechnology Transfer
Product code: Code JKL
Device class: Class 1
Regulation: 21 CFR 862.1060
Advisory panel: Clinical Chemistry
Date received: 1984-06-12
Decision date: 1984-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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