FDA-Device2014-08-13Class II
PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
PerkinElmer Health Sciences, Inc.
Hazard
Potential for demographic information and test result to be mismatch.
Sold states
Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK
Affected count
13 devices
Manufactured in
940 Winter St, N/A, Waltham, MA, United States
Products
PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2166-2014Don't want to check this manually?
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