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510(k) K970198

IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES by Scimedx Corp. — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1997
Date Received
January 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K962360 — IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES (September 30, 1996)

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