# Elias U.S.A., Inc.

- Location (FDA's records): Osceola, WI
- FDA decisions: 54 (1992–1997): 54 510(k) clearances
- Product codes: LJM (16), MID (7), JZO (5), LLL (4), LKJ (3), MOB (2), DBM (2), LRM (2), JIR (1), JZS (1), JKC (1), JZG (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 11 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Biomedical Diagnostics (Bmd) SA: 6 (https://510kreport.com/company/biomedical-diagnostics-bmd)
- Phadia US, Inc.: 4 (https://510kreport.com/company/phadia-us)
- Bio-Rad Laboratories, Inc.: 1 (https://510kreport.com/company/bio-rad-laboratories)

## Its most-cited devices
- K944168: Varelisa LA (SS-B) Antibodies (1994), cited by 2
- K950031: Varelisa Dsdna Antibodies (Farr Version) (1995), cited by 2
- K944172: Varelisa SCL-70 Antibodies (1994), cited by 2
- K944173: Varelisa JO-1 Antibodies (1994), cited by 2
- K944171: Varelisa Centromere Antibodies (1994), cited by 2
- K944169: Varelisa RO (SS-a) Antibodies (1994), cited by 1

## Recent decisions
- K964385: Elias Ana-Hep-2 (Mar 6, 1997)
- K963291: Varelisa Ana (4) Profile (Sep 30, 1996)
- K953873: Varelisa Helicobacter Pylori Antibodies (Aug 30, 1996)
- K953587: Varelisa Mpo-Anca (Jan 26, 1996)
- K953586: Varelisa PR3-Anca (Jan 26, 1996)
- K951187: Varelisa Cardiolipin Abs Screen (Oct 2, 1995)
- K951205: Varelisa Ana Profile (Apr 17, 1995)
- K951186: Varelisa Ana-4 Screen (Apr 17, 1995)

Source page: https://510kreport.com/company/elias-usa