# Theratest Laboratories, Inc.

- Location (FDA's records): Chicago, IL
- FDA decisions: 22 (1991–2010): 22 510(k) clearances
- Product codes: LJM (6), DHR (3), LLL (2), MSV (2), NHX (1), MID (1), LKJ (1), GFO (1), MOB (1), MVM (1), LKP (1), MQA (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K090753: Theratest EL-Anti-CCP/2 (Mar 5, 2010)
- K090760: Theratest EL-Anti-Tpo and Theratest EL-Anti-Thyroglobulin, Model 104-119, 103-120 (Sep 3, 2009)
- K071692: Theratest EL-TTG Iga/Igg and Theratest EL-Glia Iga/Igg Test Systems (Nov 5, 2007)
- K061376: EL-Anca: Anti-Mpo, Anti-PR3, Anti-Mpo and Anti-PR3 (Jul 20, 2006)
- K060176: EL-Acl Screen; EL-Acl Igm, Igg, Iga (Feb 7, 2006)
- K051066: Theratest EL-Ana Profiles (Oct 7, 2005)
- K040291: EL-Ana Profiles: Anti-Chromatin (Mar 11, 2004)
- K024031: The Theratest EL-Ana Profiles: Anti-Centromere (Feb 6, 2003)

Source page: https://510kreport.com/company/theratest-laboratories