DeviceClearance

THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE— 510(k) K000880

Substantially Equivalent

Zeus Scientific, Inc.

FDA 510(k) clearance K000880 for THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE, Substantially Equivalent on 2000-05-22. Applicant: Zeus Scientific, Inc.. Device class: 2.

Clearance details

Applicant
Zeus Scientific, Inc.
Product code
Code LJM
Device class
Class 2
Regulation
21 CFR 866.5100
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Branchburg, NJ, US
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