FDA applicant
Helix Diagnostics, Inc.
FDA records 15 decisions for Helix Diagnostics, Inc. (West Sacramento, CA) from 1991 to 2000: 15 510(k) clearances. Most are in product codes LLL (Extractable Antinuclear Antibody, Antigen And…) and LJM (Antinuclear Antibody (Enzyme-Labeled)…). 8 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Helix Diagnostics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Helix Diagnostics, Inc. since 2007.
Recalls per year
8in 2010
Class I Class II/III not classified
Planning a device like Helix Diagnostics, 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 “Helix”
FDA records each applicant name separately; these may or may not be the same firm.