FDA applicant
Theratest Laboratories, Inc.
FDA records 22 decisions for Theratest Laboratories, Inc. (Chicago, IL) from 1991 to 2010: 22 510(k) clearances. Most are in product codes LJM (Antinuclear Antibody (Enzyme-Labeled)…) and DHR (System, Test, Rheumatoid Factor). 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Theratest Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2026 so far, outlined.
Recalls per year
1in 2012
Class I Class II/III not classified
Planning a device like Theratest Laboratories, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report