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Theratest Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Known Names

theratest laboratories, thera-test laboratories

Recent 510(k) Clearances

K-NumberDeviceDate
K090753THERATEST EL-ANTI-CCP/2March 5, 2010
K090760THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120September 3, 2009
K071692THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMSNovember 5, 2007
K061376EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3July 20, 2006
K060176EL-ACL SCREEN; EL-ACL IGM, IGG, IGAFebruary 7, 2006
K051066THERATEST EL-ANA PROFILESOctober 7, 2005
K040291EL-ANA PROFILES: ANTI-CHROMATINMarch 11, 2004
K024031THE THERATEST EL-ANA PROFILES: ANTI-CENTROMEREFebruary 6, 2003
K024151EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN PFebruary 6, 2003
K002559EL-ANA PROFILES-2K1September 12, 2000
K982622EL-ANA PROFILES: EL-ENA/5August 13, 1998
K982150EL-ANA PROFILES: EL-ENA/4August 13, 1998
K972790THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCRDecember 5, 1997
K973882EL-B2GP1SCRDecember 5, 1997
K962050THERATEST EL-RFSCRDecember 16, 1996
K955481THERATEST KIT (MODIFICATION)March 6, 1996
K954106THERATEST LAB, INC., EL-ANASCR KITNovember 14, 1995
K950716THERATEST EL-ANA PROFILES TEST SYSTEMSeptember 26, 1995
K941398EL-RF/3 (IGM-IGG-IGA) KITJuly 28, 1995
K933712EL-RF TEST SYSTEM: EL-RF-IGM KITJanuary 28, 1994