SYNELISA CARDIOLIPIN ANTIBODIES— 510(k) K924421

Substantially Equivalent

Elias U.S.A., Inc.

FDA 510(k) clearance K924421 for SYNELISA CARDIOLIPIN ANTIBODIES, Substantially Equivalent on 1992-11-30. Applicant: Elias U.S.A., Inc.. Device class: 2.

Clearance details

Applicant
Elias U.S.A., Inc.
Product code
Code MID
Device class
Class 2
Regulation
21 CFR 866.5660
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Osceola, WI, US
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