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CZX

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Hemopexin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5490
Medical specialty
Immunology
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RecordFirmDate
HEMOPEXIN NEPHELOMETRIC ASSAY (K801432)J.T. Baker Chemical Co.1980-07-08
ANTISERUM TO HUMAN HEMOPEXIN (K790713)Kent Laboratories, Inc.1979-09-04
HEMOPEXIN NEPHELOMETRIC ASSAYS (K780250)Kallestad Laboratories, Inc.1978-02-28

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