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Rhigene, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K040711MESACUP TEST PR-3April 2, 2004
K040586MESACUP TEST MPO, MODEL 11053March 22, 2004
K040200MESACUP-2 TEST CENP-BMarch 4, 2004
K033528MESACUP-2 TEST JO-1, MODEL 10756December 22, 2003
K031308RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760September 26, 2003
K022017RHIGENE MESACUP-2 TEST RNP, MODEL M7741August 14, 2002
K022018RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560July 5, 2002
K011068RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100LApril 11, 2002
K000336RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 EJune 9, 2000
K000751RHIGENE MESACUP2 TEST- SSBMay 9, 2000
K000750RHIGENE MESACUP2 TEST- SCL-70May 9, 2000
K000755RHIGENE MESACUP2 TEST- SMMay 9, 2000
K000749RHIGENE MESACUP2 TEST- SSAMay 9, 2000
K000752RHIGENE MESACUP2 TEST- RNPMay 9, 2000
K994071RHIGENE ANA ELISA TEST SYSTEMJanuary 18, 2000