510(k) K912924

RAMBACH AGAR by Rantran, Inc. — Product Code JSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1992
Date Received
July 3, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Enterobacteriaceae
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type