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510(k) K033528

MESACUP-2 TEST JO-1, MODEL 10756 by Rhigene, Inc. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2003
Date Received
November 7, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K000751 — RHIGENE MESACUP2 TEST- SSB (May 9, 2000)
  • K000750 — RHIGENE MESACUP2 TEST- SCL-70 (May 9, 2000)

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