HEP-2 GENCELLS— 510(k) K852206

Substantially Equivalent

Genus Diagnostics

FDA 510(k) clearance K852206 for HEP-2 GENCELLS, Substantially Equivalent on 1985-06-04. Applicant: Genus Diagnostics.

Clearance details

Applicant: Genus Diagnostics
Product code: Code KIR
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 ↗

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