510(k) K841209

SELECTIVE AND DIFFERENTIAL by Smith River Biologicals — Product Code JSI

K841209 is an FDA 510(k) premarket notification submitted by Smith River Biologicals for the device "SELECTIVE AND DIFFERENTIAL". The FDA issued a decision of Substantially Equivalent on April 17, 1984. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Smith River Biologicals has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1984
Date Received
March 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Differential
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type