ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control

FDA 510(k) Premarket Notification · Submission K191578 · Applicant: Siemens Healthcare Diagnostics, Inc.

Public Record 510(k) Submission Decision Date: 2019-07-17 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K191578.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K191578

Applicant / Sponsor

Siemens Healthcare Diagnostics, Inc.

Device Name

ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control

Product Code

QFO

Decision Date

2019-07-17

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Microbiology (MI)

Clearance Type

Traditional

Third Party Flag

Date Received

2019-06-14

Related Establishments / Registrations

Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
EPITOPE DIAGNOSTICS, INC. Registration: 2032839 View Registration
DIASORIN INC. Registration: 2182595 View Registration
ROCHE MOLECULAR SYSTEMS, INC. Registration: 2243471 View Registration
CHEMBIO DIAGNOSTIC SYSTEMS, INC. Registration: 2431980 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
Chembio Diagnostic Systems Registration: 3026565854 View Registration
INBIOS INTERNATIONAL, INC. Registration: 3032562 View Registration

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.