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510(k) K930987

CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) by The Binding Site, Ltd. — Product Code KTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1993
Date Received
February 25, 1993
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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