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Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

FDA product code PER · 3 cleared devices

Class 1 Clinical Chemistry
Regulation
21 CFR 862.2750
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2005-02-22 – 2013-08-02

Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis.

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