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510(k) K871252

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

K871252 is an FDA 510(k) premarket notification submitted by Advanced Polymer Systems, Inc. for the device "RSR CARD TEST". The FDA issued a decision of Substantially Equivalent on August 6, 1987. The device falls under product code GMQ (Antigens, Nontreponemal, All), a Class II device regulated under 21 CFR 866.3820.

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

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FDA data resources