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DFK

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Igg (Fab Fragment Specific), Antigen, Antiserum, Control
Device class
Class I (low risk)
Regulation
21 CFR 866.5520
Medical specialty
Immunology
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RecordFirmDate
ANTISERA TO HUMAN FRAGMENT (K790711)Kent Laboratories, Inc.1979-09-04
ANTISERA TO HUMAN FAB FRAGMENT (K771243)Kent Laboratories, Inc.1977-08-03
FLOR. CONJUG. HUMAN FAB FRAGMENT (K770670)Kent Laboratories, Inc.1977-04-28

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