FDA applicant
Alpkem Corp.
FDA records 33 decisions for Alpkem Corp. (Clackamas, OR) from 1985 to 1990: 33 510(k) clearances. Most are in product codes JJF (Analyzer, Chemistry, Micro, For Clinical Use) and CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme…). 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 Alpkem Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Alpkem Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Alpkem Corp.’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