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510(k) K831408

DNA FLOR by Medastat Scientific Corp. — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1983
Date Received
May 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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