GSQ — Antiserum, Vibrio Cholerae, All Varieties Class II

FDA Device Classification

FDA product code GSQ covers "Antiserum, Vibrio Cholerae, All Varieties", a Class II medical device regulated under 21 CFR 866.3930. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GSQ
Device Class
Class II
Regulation Number
866.3930
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K954995guardian scientificQUIX RAPID CHOLERA STRIP TESTAugust 15, 1996
K932622new horizons diagnosticsCHOLERA SMART(TM)June 27, 1995
K922432new horizons diagnosticsCHOLERASCREENDecember 7, 1992