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GNG — Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6 Class I

FDA Device Classification

Classification Details

Product Code
GNG
Device Class
Class I
Regulation Number
866.3145
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K921618virion (u.s.)COXSACKIE VIRUS B1-B6 CF ANTIGENSJune 29, 1992
K850003hillcrest biologicalsCOXSACKIE B SERIES CF ANTIGENSMarch 5, 1985