Atlas FDA

GNK

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Antisera, Cf, Echovirus 1-34
Device class
Class I (low risk)
Regulation
21 CFR 866.3205
Medical specialty
Microbiology
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RecordFirmDate
ECHO TYPE 16 CF ANTIGEN (K853156)Hillcrest Biologicals1985-11-07
ECHO TYPE 30 CF ANTIGEN (K853165)Hillcrest Biologicals1985-11-07
ECHO TYPE 11 CF ANTIGEN (K853157)Hillcrest Biologicals1985-11-07

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