DeviceClearance

ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY— 510(k) K082759

Substantially Equivalent

Phadia US, Inc.

FDA 510(k) clearance K082759 for ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY, Substantially Equivalent on 2009-04-10. Applicant: Phadia US, Inc..

Clearance details

Applicant
Phadia US, Inc.
Product code
Code LKJ
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Portage, MI, US
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