HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8— 510(k) K844897

Name: FDA 510(k) clearance K844897
Creator: U.S. Food and Drug Administration
Published: 1985-03-22

Substantially Equivalent

Medical Specialties Laboratories

FDA 510(k) clearance K844897 for HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8, Substantially Equivalent on 1985-03-22. Applicant: Medical Specialties Laboratories. Device class: 2.

Clearance details

Applicant: Medical Specialties Laboratories
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1984-12-17
Decision date: 1985-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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