EBV-VCA IGG ELISA TEST SYSTEM— 510(k) K981812

Clearance details

Applicant

Diamedix Corp.

Product code

Code LSE

Device class

Class 1

Regulation

21 CFR 866.3235

Advisory panel

Microbiology

Date received

1998-05-22

Decision date

1999-03-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Columbia, MD, US

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• Z-1686-2016 — Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.Class II·Terminated·Diamedix Corporation·20141020

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981812.