Medical Device Manufacturer · US , Osceola , WI

Elias U.S.A., Inc.

54 submissions · 54 cleared · Since 1992
54
Total
54
Cleared
0
Denied

Elias U.S.A., Inc. — FDA 510(k) Submissions

Elias U.S.A., Inc. has submitted 54 FDA 510(k) premarket notifications since 1992, of which 54 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Antinuclear Antibody (enzyme-labeled), Antigen, Controls, System, Test, Anticardiolipin Immunological, System, Test, Thyroid Autoantibody, Extractable Antinuclear Antibody, Antigen And Control, Antinuclear Antibody, Antigen, Control . Use the specialty filter in the sidebar to narrow results.

54 devices
1–25 of 54
ELIAS ANA-HEP-2
K964385 · LJM Antinuclear Antibody... · Immunology
Mar 1997 122d
VARELISA ANA (4) PROFILE
K963291 · LJM Antinuclear Antibody... · Immunology
Sep 1996 40d
VARELISA HELICOBACTER PYLORI ANTIBODIES
K953873 · LYR Helicobacter Pylori · Microbiology
Aug 1996 379d
VARELISA PR3-ANCA
K953586 · MOB Test System,... · Immunology
Jan 1996 178d
VARELISA MPO-ANCA
K953587 · MOB Test System,... · Immunology
Jan 1996 178d
VARELISA CARDIOLIPIN ABS SCREEN
K951187 · MID System, Test,... · Immunology
Oct 1995 200d
VARELISA COMBINED DNA ANTIBODIES EIA
K944334 · LRM Anti-dna Antibody... · Immunology
Apr 1995 223d
VARELISA ANA-4 SCREEN
K951186 · LJM Antinuclear Antibody... · Immunology
Apr 1995 32d
VARELISA ANA PROFILE
K951205 · LJM Antinuclear Antibody... · Immunology
Apr 1995 31d
VARELISA PARIETAL CELL ANTIBODIES
K951206 · MLE Enzyme Immunoassay,... · Immunology
Apr 1995 31d
VARELISA HISTONE ANTIBODIES
K951207 · LJM Antinuclear Antibody... · Immunology
Apr 1995 31d
VARELISA DSDNA ANTIBODIES (FARR VERSION)
K950031 · LRM Anti-dna Antibody... · Immunology
Mar 1995 65d
VARELISA M2 ANTIBODIES
K945607 · DBM Antimitochondrial... · Immunology
Jan 1995 70d
VARELISA RNP-SM ANTIBODIES
K944167 · LJM Antinuclear Antibody... · Immunology
Dec 1994 118d
VARELISA LA (SS-B) ANTIBODIES
K944168 · LJM Antinuclear Antibody... · Immunology
Dec 1994 118d
VARELISA RO (SS-A) ANTIBODIES
K944169 · LJM Antinuclear Antibody... · Immunology
Dec 1994 118d
VARELISA SM ANTIBODIES
K944170 · LJM Antinuclear Antibody... · Immunology
Dec 1994 118d
VARELISA CENTROMERE ANTIBODIES
K944171 · LJM Antinuclear Antibody... · Immunology
Dec 1994 118d
VARELISA SCL-70 ANTIBODIES
K944172 · LJM Antinuclear Antibody... · Immunology
Dec 1994 118d
VARELISA JO-1 ANTIBODIES
K944173 · LJM Antinuclear Antibody... · Immunology
Dec 1994 118d
ELIAS CARDIOLIPIN ANTIBODIES
K940403 · MID System, Test,... · Immunology
Sep 1994 236d
SYN ENA SCREEN (PIN PLATE)
K940229 · LLL Extractable Antinuclear... · Immunology
May 1994 113d
ELIAS ENA SCREEN (MICROTITER PLATE)
K940622 · LLL Extractable Antinuclear... · Immunology
May 1994 113d
SYNELISA ANA TOTAL
K935468 · LJM Antinuclear Antibody... · Immunology
Mar 1994 133d
ELIAS ANA TOTAL
K940641 · LJM Antinuclear Antibody... · Immunology
Mar 1994 39d
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