510(k) K923892

SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA by Smith River Biologicals — Product Code JSO

K923892 is an FDA 510(k) premarket notification submitted by Smith River Biologicals for the device "SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA". The FDA issued a decision of Substantially Equivalent on June 21, 1993. 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. Smith River Biologicals has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1993
Date Received
August 4, 1992
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