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510(k) K030775

AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM by Immuno Concepts, N.A. , Ltd. — Product Code LKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2003
Date Received
March 11, 2003
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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

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