FDA-Device2017-04-19Class II
Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
PerkinElmer Life and Analytical Sciences, Wallac, OY
Hazard
Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
Sold states
Worldwide Distribution - US including AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, NV, OH, OK, OR, TN, TX, VA; and Internationally to Canada and Brazil
Affected count
29
Manufactured in
Mustionkatu 6, P.O. Box 10, Turku, N/A, Finland
Products
Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1761-2017Don't want to check this manually?
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