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510(k) K913360

ANTI-RETICULIN ANTIBODY (ARA) TEST by Immco Diagnostics, Inc. — Product Code DBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1994
Date Received
July 29, 1991
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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