510(k) K850970

BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA by Granite Diagnostics, Inc. — Product Code JSJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1985
Date Received
March 8, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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