510(k) K871252

RSR CARD TEST by Advanced Polymer Systems, Inc. — Product Code GMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1987
Date Received
March 30, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Nontreponemal, All
Device Class
Class II
Regulation Number
866.3820
Review Panel
MI
Submission Type