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DEY

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Igm, Peroxidase, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5550
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
VENTANA RED DETECTION KIT (K932386)Ventana Medical Systems, Inc.1993-08-09
DAB DETECTION KIT (K920600)Ventana Medical Systems, Inc.1992-05-11
AEC DETECTION KIT (K920566)Ventana Medical Systems, Inc.1992-05-08

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Every clearance here is in the API, with alerts when new ones post.