ADVIA CENTAUR HAVM ASSAY— 510(k) K081716

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K081716 for ADVIA CENTAUR HAVM ASSAY, Substantially Equivalent on 2008-07-17. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Siemens Healthcare Diagnostics, Inc.
Product code
Code LOL
Device class
Class 2
Regulation
21 CFR 866.3310
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Tarrytown, NY, US
Download summary PDFView on FDA.gov ↗

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