FDA applicant
Syn-Kit, Inc.
FDA records 34 decisions for Syn-Kit, Inc. (Mchenry, IL) from 1980 to 1986: 34 510(k) clearances. Most are in product codes JIL (Method, Enzymatic, Glucose (Urinary…) and DCN (System, Test, C-Reactive Protein). 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 Syn-Kit, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Syn-Kit, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Syn-Kit, 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