FDA applicant
Micro Detect, Inc.
FDA records 11 decisions for Micro Detect, Inc. (Tustin, CA) from 1998 to 2001: 11 510(k) clearances. Most are in product codes LJM (Antinuclear Antibody (Enzyme-Labeled)…) and LYR (Helicobacter Pylori). 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 Micro Detect, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Micro Detect, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Micro Detect, 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