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510(k) K944191

ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER by Light Diagnostics — Product Code DBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1995
Date Received
August 29, 1994
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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