CONTROL TM 8— 510(k) K823794

Substantially Equivalent

General Diagnostics

FDA 510(k) clearance K823794 for CONTROL TM 8, Substantially Equivalent on 1983-01-14. Applicant: General Diagnostics. Device class: 2.

Clearance details

Applicant: General Diagnostics
Product code: Code GLQ
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1982-12-16
Decision date: 1983-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.