FIBRI QUIK— 510(k) K802117

Substantially Equivalent

General Diagnostics

FDA 510(k) clearance K802117 for FIBRI QUIK, Substantially Equivalent on 1980-09-26. Applicant: General Diagnostics. Device class: 2.

Clearance details

Applicant: General Diagnostics
Product code: Code GJA
Device class: Class 2
Regulation: 21 CFR 864.7875
Advisory panel: Hematology
Date received: 1980-09-04
Decision date: 1980-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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