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510(k) K821576

ANTINUCLEAR ANTIBODY SCREEN FLOURESC by Immuno-Products Industries — Product Code DBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1982
Date Received
May 28, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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