LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III— 510(k) K864137

Name: FDA 510(k) clearance K864137
Creator: U.S. Food and Drug Administration
Published: 1986-11-07

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K864137 for LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III, Substantially Equivalent on 1986-11-07. Applicant: Bio-Rad. Device class: 1.

Clearance details

Applicant: Bio-Rad
Product code: Code KIJ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1986-10-21
Decision date: 1986-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, CA, US

Download summary PDF View on FDA.gov ↗

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