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

FDA Device Classification

FDA product code GNG covers "Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6", a Class I medical device regulated under 21 CFR 866.3145. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.

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