510(k) K792421

DECARBOXYLASE BROTH BASE WITH OR WITH- by Isle Media and Sterile Products, Inc. — Product Code JSH

K792421 is an FDA 510(k) premarket notification submitted by Isle Media and Sterile Products, Inc. for the device "DECARBOXYLASE BROTH BASE WITH OR WITH-". The FDA issued a decision of Substantially Equivalent on December 31, 1979. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. Isle Media and Sterile Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1979
Date Received
November 27, 1979
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