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510(k) K902237

MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT by Medica Corp. — Product Code DBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1990
Date Received
May 18, 1990
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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