510(k) K122187

VRESELECT CULTURE MEDIUM by Bio-Rad — Product Code JSO

K122187 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "VRESELECT CULTURE MEDIUM". The FDA issued a decision of Substantially Equivalent on November 6, 2012. The device falls under product code JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar), a Class II device regulated under 21 CFR 866.1700. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2012
Date Received
July 24, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class
Class II
Regulation Number
866.1700
Review Panel
MI
Submission Type