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Elias U.S.A., Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
54
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K964385ELIAS ANA-HEP-2March 6, 1997
K963291VARELISA ANA (4) PROFILESeptember 30, 1996
K953873VARELISA HELICOBACTER PYLORI ANTIBODIESAugust 30, 1996
K953586VARELISA PR3-ANCAJanuary 26, 1996
K953587VARELISA MPO-ANCAJanuary 26, 1996
K951187VARELISA CARDIOLIPIN ABS SCREENOctober 2, 1995
K944334VARELISA COMBINED DNA ANTIBODIES EIAApril 17, 1995
K951205VARELISA ANA PROFILEApril 17, 1995
K951186VARELISA ANA-4 SCREENApril 17, 1995
K951206VARELISA PARIETAL CELL ANTIBODIESApril 17, 1995
K951207VARELISA HISTONE ANTIBODIESApril 17, 1995
K950031VARELISA DSDNA ANTIBODIES (FARR VERSION)March 10, 1995
K945607VARELISA M2 ANTIBODIESJanuary 24, 1995
K944167VARELISA RNP-SM ANTIBODIESDecember 22, 1994
K944171VARELISA CENTROMERE ANTIBODIESDecember 22, 1994
K944173VARELISA JO-1 ANTIBODIESDecember 22, 1994
K944172VARELISA SCL-70 ANTIBODIESDecember 22, 1994
K944170VARELISA SM ANTIBODIESDecember 22, 1994
K944168VARELISA LA (SS-B) ANTIBODIESDecember 22, 1994
K944169VARELISA RO (SS-A) ANTIBODIESDecember 22, 1994