510(k) K851344

OXIDATIVE FORMENTIVE MEDIUM by Micro Media Laboratories — Product Code JSH

K851344 is an FDA 510(k) premarket notification submitted by Micro Media Laboratories for the device "OXIDATIVE FORMENTIVE MEDIUM". The FDA issued a decision of Substantially Equivalent on April 22, 1985. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. Micro Media Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1985
Date Received
April 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Differential
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type