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510(k) K880144

STANBIO SYPHILIS RPR TEST, NO. 1170 by Stanbio Laboratory — Product Code GMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1988
Date Received
January 13, 1988
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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