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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
K951186VARELISA ANA-4 SCREENApril 17, 1995
K951206VARELISA PARIETAL CELL ANTIBODIESApril 17, 1995
K951205VARELISA ANA PROFILEApril 17, 1995
K951207VARELISA HISTONE ANTIBODIESApril 17, 1995
K944334VARELISA COMBINED DNA ANTIBODIES EIAApril 17, 1995
K950031VARELISA DSDNA ANTIBODIES (FARR VERSION)March 10, 1995
K945607VARELISA M2 ANTIBODIESJanuary 24, 1995
K944168VARELISA LA (SS-B) ANTIBODIESDecember 22, 1994
K944169VARELISA RO (SS-A) ANTIBODIESDecember 22, 1994
K944171VARELISA CENTROMERE ANTIBODIESDecember 22, 1994
K944173VARELISA JO-1 ANTIBODIESDecember 22, 1994
K944170VARELISA SM ANTIBODIESDecember 22, 1994
K944172VARELISA SCL-70 ANTIBODIESDecember 22, 1994
K944167VARELISA RNP-SM ANTIBODIESDecember 22, 1994