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GNK – Antisera, Cf, Echovirus 1-34
Antisera, Cf, Echovirus 1-34
FDA product code
GNK
· Class I (low risk) · 21 CFR 866.3205 ·
Microbiology
3
510(k) clearances
0
PMA approvals
0
recalls
Manufacturers
Hillcrest Biologicals
3
510(k) clearances
510(k)
Device
Applicant
Decision
K853165
Echo Type 30 CF Antigen
GNK · Traditional
Hillcrest Biologicals
11/07/1985
SE
K853157
Echo Type 11 CF Antigen
GNK · Traditional
Hillcrest Biologicals
11/07/1985
SE
K853156
Echo Type 16 CF Antigen
GNK · Traditional
Hillcrest Biologicals
11/07/1985
SE