LYPHOCHEK HEMOSTASIS, MODELS 798, 799— 510(k) K020878

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K020878 for LYPHOCHEK HEMOSTASIS, MODELS 798, 799, Substantially Equivalent on 2002-04-15. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code GGC
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2002-03-18
Decision date: 2002-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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