QBC FIBRINOGEN— 510(k) K920258

Name: FDA 510(k) clearance K920258
Creator: U.S. Food and Drug Administration
Published: 1992-06-26

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K920258 for QBC FIBRINOGEN, Substantially Equivalent on 1992-06-26. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code KQJ
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1992-01-21
Decision date: 1992-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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