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510(k) K040200

MESACUP-2 TEST CENP-B by Rhigene, Inc. — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2004
Date Received
January 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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  • K022017 — RHIGENE MESACUP-2 TEST RNP, MODEL M7741 (August 14, 2002)
  • K022018 — RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 (July 5, 2002)
  • K011068 — RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L (April 11, 2002)
  • K000336 — RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E (June 9, 2000)
  • K000751 — RHIGENE MESACUP2 TEST- SSB (May 9, 2000)
  • K000750 — RHIGENE MESACUP2 TEST- SCL-70 (May 9, 2000)

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