Company ยท US
Elias U.S.A., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 1997. Name variants (Inc, Corp, punctuation) are merged.
54510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 16 |
| MID | System, Test, Anticardiolipin Immunological | 7 |
| JZO | System, Test, Thyroid Autoantibody | 5 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 4 |
| LKJ | Antinuclear Antibody, Antigen, Control | 3 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 2 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 |
| CGR | Radioimmunoassay, Cortisol | 1 |
| DBJ | Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DHC | System, Test, Systemic Lupus Erythematosus | 1 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 1 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 1 |
| JZS | Electrophoresis Instrumentation | 1 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 1 |
| LKP | Anti-Sm Antibody, Antigen And Control | 1 |
| LYR | Helicobacter Pylori | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 6, 1997 | K964385 | ELIAS ANA-HEP-2 Elias U.S.A., Inc. | LJM |
| Sep 30, 1996 | K963291 | VARELISA ANA (4) PROFILE Elias U.S.A., Inc. | LJM |
| Aug 30, 1996 | K953873 | VARELISA HELICOBACTER PYLORI ANTIBODIES Elias U.S.A., Inc. | LYR |
| Jan 26, 1996 | K953587 | VARELISA MPO-ANCA Elias U.S.A., Inc. | MOB |
| Jan 26, 1996 | K953586 | VARELISA PR3-ANCA Elias U.S.A., Inc. | MOB |
| Oct 2, 1995 | K951187 | VARELISA CARDIOLIPIN ABS SCREEN Elias U.S.A., Inc. | MID |
| Apr 17, 1995 | K951207 | VARELISA HISTONE ANTIBODIES Elias U.S.A., Inc. | LJM |
| Apr 17, 1995 | K951206 | VARELISA PARIETAL CELL ANTIBODIES Elias U.S.A., Inc. | MLE |
| Apr 17, 1995 | K951205 | VARELISA ANA PROFILE Elias U.S.A., Inc. | LJM |
| Apr 17, 1995 | K951186 | VARELISA ANA-4 SCREEN Elias U.S.A., Inc. | LJM |
| Apr 17, 1995 | K944334 | VARELISA COMBINED DNA ANTIBODIES EIA Elias U.S.A., Inc. | LRM |
| Mar 10, 1995 | K950031 | VARELISA DSDNA ANTIBODIES (FARR VERSION) Elias U.S.A., Inc. | LRM |
| Jan 24, 1995 | K945607 | VARELISA M2 ANTIBODIES Elias U.S.A., Inc. | DBM |
| Dec 22, 1994 | K944173 | VARELISA JO-1 ANTIBODIES Elias U.S.A., Inc. | LJM |
| Dec 22, 1994 | K944172 | VARELISA SCL-70 ANTIBODIES Elias U.S.A., Inc. | LJM |
| Dec 22, 1994 | K944171 | VARELISA CENTROMERE ANTIBODIES Elias U.S.A., Inc. | LJM |
| Dec 22, 1994 | K944170 | VARELISA SM ANTIBODIES Elias U.S.A., Inc. | LJM |
| Dec 22, 1994 | K944169 | VARELISA RO (SS-A) ANTIBODIES Elias U.S.A., Inc. | LJM |
| Dec 22, 1994 | K944168 | VARELISA LA (SS-B) ANTIBODIES Elias U.S.A., Inc. | LJM |
| Dec 22, 1994 | K944167 | VARELISA RNP-SM ANTIBODIES Elias U.S.A., Inc. | LJM |
| Sep 20, 1994 | K940403 | ELIAS CARDIOLIPIN ANTIBODIES Elias U.S.A., Inc. | MID |
| May 11, 1994 | K940622 | ELIAS ENA SCREEN (MICROTITER PLATE) Elias U.S.A., Inc. | LLL |
| May 11, 1994 | K940229 | SYN ENA SCREEN (PIN PLATE) Elias U.S.A., Inc. | LLL |
| Mar 25, 1994 | K940641 | ELIAS ANA TOTAL Elias U.S.A., Inc. | LJM |
| Mar 25, 1994 | K935468 | SYNELISA ANA TOTAL Elias U.S.A., Inc. | LJM |
| Mar 22, 1994 | K935469 | SYNELISA DHEA-SULFATE Elias U.S.A., Inc. | JKC |
| Jan 24, 1994 | K935288 | SYNELISA CARDIOLIPIN ANTIBODIES Elias U.S.A., Inc. | MID |
| Dec 8, 1993 | K933393 | ELIAS CARDIOLIPIN IGG ANTIBODIES Elias U.S.A., Inc. | MID |
| Dec 8, 1993 | K933392 | ELIAS CARDIOLIPIN IGM ANTIBODIES Elias U.S.A., Inc. | MID |
| Dec 3, 1993 | K932206 | SYNELISA ANA PROFILE Elias U.S.A., Inc. | LJM |
| Nov 5, 1993 | K933128 | SYNELISA PROGESTERONE Elias U.S.A., Inc. | JLS |
| Sep 27, 1993 | K931177 | SYNELISA CORTISOL Elias U.S.A., Inc. | CGR |
| Sep 24, 1993 | K931255 | SYNELISA CENP-B ANTIBODIES Elias U.S.A., Inc. | LKJ |
| Aug 23, 1993 | K933123 | SYNELISA TG ANTIBODIES/TPO ANTIBODIES Elias U.S.A., Inc. | JZS |
| Aug 23, 1993 | K932302 | SYLNELISA HISTONE ANTIBODIES Elias U.S.A., Inc. | LKJ |
| Aug 3, 1993 | K930422 | SYNELISA PARIETAL CELL ANTIBODIES Elias U.S.A., Inc. | DBJ |
| Jun 11, 1993 | K930209 | SYNELISA RO ABS / LA ABS Elias U.S.A., Inc. | LJM |
| May 11, 1993 | K930143 | AYNELISA M2-ANTIBODIES Elias U.S.A., Inc. | DBM |
| May 11, 1993 | K930142 | SYNELISA U1-SNRNP (68KDA)-ANTIBODIES Elias U.S.A., Inc. | LKO |
| May 11, 1993 | K930141 | SYNELISA SM ABS/RNP-SM ABS Elias U.S.A., Inc. | LKP |
| Apr 6, 1993 | K930417 | SYNELISA SCL-70 ANTIBODIES Elias U.S.A., Inc. | LLL |
| Apr 6, 1993 | K930281 | SYNELISA JO-1 ANTIBODIES Elias U.S.A., Inc. | LLL |
| Mar 10, 1993 | K930421 | ELIAS DSDNA ABS Elias U.S.A., Inc. | DHC |
| Jan 14, 1993 | K925923 | ELIAS TMAB Elias U.S.A., Inc. | JZO |
| Jan 14, 1993 | K925922 | ELIAS TGAB Elias U.S.A., Inc. | JZO |
| Dec 1, 1992 | K921132 | SYN ELISA DSDNA ANTIBODIES Elias U.S.A., Inc. | LKJ |
| Nov 30, 1992 | K924421 | SYNELISA CARDIOLIPIN ANTIBODIES Elias U.S.A., Inc. | MID |
| Jul 28, 1992 | K921787 | SYNELISA TPO ANTIBODIES Elias U.S.A., Inc. | JNL |
| Jun 4, 1992 | K921250 | SYNELISA CARDIOLIPIN ANTIBODIES Elias U.S.A., Inc. | MID |
| May 28, 1992 | K920132 | SYN ELISA BETA 2 MICROGLOBULIN TEST KIT Elias U.S.A., Inc. | JZG |
Newest 50 of 54.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||