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510(k) K011068

RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L by Rhigene, Inc. — Product Code KTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2002
Date Received
April 9, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Indirect Immunofluorescent Solid Phase
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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