Elias U.S.A., Inc.
Osceola, WI, US
Elias U.S.A., Inc. appears in FDA device records in Osceola, WI. FDA records list 54 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 54
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 54FDA records hold 54 510(k) clearances for Elias U.S.A., Inc. between 1992 and 1997. The busiest year on record is 1993, with 18. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 9 |
| 1993 | 18 |
| 1994 | 14 |
| 1995 | 8 |
| 1996 | 4 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K964385 | ELIAS ANA-HEP-2 | LJM | Substantially Equivalent | |
| K963291 | VARELISA ANA (4) PROFILE | LJM | Substantially Equivalent | |
| K953873 | VARELISA HELICOBACTER PYLORI ANTIBODIES | LYR | Substantially Equivalent | |
| K953587 | VARELISA MPO-ANCA | MOB | Substantially Equivalent | |
| K953586 | VARELISA PR3-ANCA | MOB | Substantially Equivalent | |
| K951187 | VARELISA CARDIOLIPIN ABS SCREEN | MID | Substantially Equivalent | |
| K951207 | VARELISA HISTONE ANTIBODIES | LJM | Substantially Equivalent | |
| K951206 | VARELISA PARIETAL CELL ANTIBODIES | MLE | Substantially Equivalent | |
| K951205 | VARELISA ANA PROFILE | LJM | Substantially Equivalent | |
| K951186 | VARELISA ANA-4 SCREEN | LJM | Substantially Equivalent | |
| K944334 | VARELISA COMBINED DNA ANTIBODIES EIA | LRM | Substantially Equivalent | |
| K950031 | VARELISA DSDNA ANTIBODIES (FARR VERSION) | LRM | Substantially Equivalent | |
| K945607 | VARELISA M2 ANTIBODIES | DBM | Substantially Equivalent | |
| K944173 | VARELISA JO-1 ANTIBODIES | LJM | Substantially Equivalent | |
| K944172 | VARELISA SCL-70 ANTIBODIES | LJM | Substantially Equivalent | |
| K944171 | VARELISA CENTROMERE ANTIBODIES | LJM | Substantially Equivalent | |
| K944170 | VARELISA SM ANTIBODIES | LJM | Substantially Equivalent | |
| K944169 | VARELISA RO (SS-A) ANTIBODIES | LJM | Substantially Equivalent | |
| K944168 | VARELISA LA (SS-B) ANTIBODIES | LJM | Substantially Equivalent | |
| K944167 | VARELISA RNP-SM ANTIBODIES | LJM | Substantially Equivalent | |
| K940403 | ELIAS CARDIOLIPIN ANTIBODIES | MID | Substantially Equivalent | |
| K940622 | ELIAS ENA SCREEN (MICROTITER PLATE) | LLL | Substantially Equivalent | |
| K940229 | SYN ENA SCREEN (PIN PLATE) | LLL | Substantially Equivalent | |
| K940641 | ELIAS ANA TOTAL | LJM | Substantially Equivalent | |
| K935468 | SYNELISA ANA TOTAL | LJM | Substantially Equivalent | |
| K935469 | SYNELISA DHEA-SULFATE | JKC | Substantially Equivalent | |
| K935288 | SYNELISA CARDIOLIPIN ANTIBODIES | MID | Substantially Equivalent | |
| K933393 | ELIAS CARDIOLIPIN IGG ANTIBODIES | MID | Substantially Equivalent | |
| K933392 | ELIAS CARDIOLIPIN IGM ANTIBODIES | MID | Substantially Equivalent | |
| K932206 | SYNELISA ANA PROFILE | LJM | Substantially Equivalent | |
| K933128 | SYNELISA PROGESTERONE | JLS | Substantially Equivalent | |
| K931177 | SYNELISA CORTISOL | CGR | Substantially Equivalent | |
| K931255 | SYNELISA CENP-B ANTIBODIES | LKJ | Substantially Equivalent | |
| K933123 | SYNELISA TG ANTIBODIES/TPO ANTIBODIES | JZS | Substantially Equivalent | |
| K932302 | SYLNELISA HISTONE ANTIBODIES | LKJ | Substantially Equivalent | |
| K930422 | SYNELISA PARIETAL CELL ANTIBODIES | DBJ | Substantially Equivalent | |
| K930209 | SYNELISA RO ABS / LA ABS | LJM | Substantially Equivalent | |
| K930143 | AYNELISA M2-ANTIBODIES | DBM | Substantially Equivalent | |
| K930142 | SYNELISA U1-SNRNP (68KDA)-ANTIBODIES | LKO | Substantially Equivalent | |
| K930141 | SYNELISA SM ABS/RNP-SM ABS | LKP | Substantially Equivalent | |
| K930417 | SYNELISA SCL-70 ANTIBODIES | LLL | Substantially Equivalent | |
| K930281 | SYNELISA JO-1 ANTIBODIES | LLL | Substantially Equivalent | |
| K930421 | ELIAS DSDNA ABS | DHC | Substantially Equivalent | |
| K925923 | ELIAS TMAB | JZO | Substantially Equivalent | |
| K925922 | ELIAS TGAB | JZO | Substantially Equivalent | |
| K921132 | SYN ELISA DSDNA ANTIBODIES | LKJ | Substantially Equivalent | |
| K924421 | SYNELISA CARDIOLIPIN ANTIBODIES | MID | Substantially Equivalent | |
| K921787 | SYNELISA TPO ANTIBODIES | JNL | Substantially Equivalent | |
| K921250 | SYNELISA CARDIOLIPIN ANTIBODIES | MID | Substantially Equivalent | |
| K920132 | SYN ELISA BETA 2 MICROGLOBULIN TEST KIT | JZG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- LKOAnti-Rnp Antibody, Antigen And Control
- LKPAnti-Sm Antibody, Antigen And Control
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LKJAntinuclear Antibody, Antigen, Control
- DBJAntiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
- JZSElectrophoresis Instrumentation
- MLEEnzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
- LLLExtractable Antinuclear Antibody, Antigen And Control
- LYRHelicobacter Pylori
- JNLImmunochemical, Thyroglobulin Autoantibody
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- CGRRadioimmunoassay, Cortisol
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- JLSRadioimmunoassay, Progesterone
- MIDSystem, Test, Anticardiolipin Immunological
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- DHCSystem, Test, Systemic Lupus Erythematosus
- JZOSystem, Test, Thyroid Autoantibody
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain