FDA applicant
Microgenics Corp.
FDA records 128 decisions for Microgenics Corp. (Concord, CA) from 1985 to 2024: 126 510(k) clearances and 2 De Novo grants. Most are in product codes DJG (Enzyme Immunoassay, Opiates) and KXT (Enzyme Immunoassay, Digoxin). Since 2016 its 510(k)s took a median of 134 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 52 predicates, 19 of them its own earlier devices. 10 recalls are linked to its devices.
FDA’s records also spell it “Microgenics Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Microgenics Corp.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Microgenics Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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