MCCOY GENCELLS— 510(k) K852204

Substantially Equivalent

Genus Diagnostics

FDA 510(k) clearance K852204 for MCCOY GENCELLS, Substantially Equivalent on 1985-06-04. Applicant: Genus Diagnostics. Device class: 1.

Clearance details

Applicant: Genus Diagnostics
Product code: Code KIR
Device class: Class 1
Regulation: 21 CFR 864.2280
Advisory panel: Hematology
Date received: 1985-05-21
Decision date: 1985-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Genus Diagnostics

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K851928 — HEK GENCELLS1985-05-20

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