510(k) K954784

DRYSIDE NEISSERIA by Difco Laboratories, Inc. — Product Code LTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1996
Date Received
October 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test Reagents, Neisseria Gonorrhoeae Biochemical
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type