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Diamedix Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
68
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K093101MAGO 4SJanuary 21, 2011
K021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEMJuly 9, 2002
K013956DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREENJanuary 8, 2002
K013628DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEMDecember 21, 2001
K012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEMOctober 26, 2001
K012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEMOctober 26, 2001
K012797DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEMSeptember 28, 2001
K012795DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEMSeptember 28, 2001
K012053DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEMAugust 20, 2001
K002262DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEMNovember 28, 2000
K001875DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEMAugust 21, 2000
K001767DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEMAugust 7, 2000
K001707DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEMJuly 7, 2000
K994424DIAMEDIX IS-ANTI-DSDNA TEST SYSTEMFebruary 18, 2000
K993294DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEMOctober 25, 1999
K981812EBV-VCA IGG ELISA TEST SYSTEMMarch 4, 1999
K981829IS EBV-EBNA-1 IGG ELISA TEST SYSTEMFebruary 16, 1999
K981831IS EBV-EA-D IGG ELISA TEST SYSTEMFebruary 16, 1999
K981729IS-RUBELLA IGG TEST SYSTEMJanuary 28, 1999
K981306DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEMSeptember 29, 1998