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510(k) K993633

SYNTHETIC VDRL ANTIGEN by Centers For Disease Control and Prevention — Product Code GMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2000
Date Received
October 27, 1999
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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