HFF GENCELLS— 510(k) K850990

Substantially Equivalent

Bioassay Systems Research Corp.

FDA 510(k) clearance K850990 for HFF GENCELLS, Substantially Equivalent on 1985-04-12. Applicant: Bioassay Systems Research Corp.. Device class: 1.

Clearance details

Applicant: Bioassay Systems Research Corp.
Product code: Code KIT
Device class: Class 1
Regulation: 21 CFR 864.2220
Advisory panel: Hematology
Date received: 1985-03-11
Decision date: 1985-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

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