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510(k) K872085

THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS by Immunodiagnostics, Ltd. — Product Code LSW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1987
Date Received
June 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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