FDA applicant
Thera-Test Laboratories, Inc.
FDA records 1 decision for Thera-Test Laboratories, Inc. (Lombard, IL) in 2009: 1 510(k) clearance. All are in product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2…). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Thera-Test Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2009
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like Thera-Test 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) ReportOther applicant names beginning “Thera-Test”
FDA records each applicant name separately; these may or may not be the same firm.