Atlas FDA

DGH

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Igd, Peroxidase, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
ANTI-GM & ANTI-KM TYPING SERUMS (K812076)Biotest-Serum-Institut1981-08-12

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