510(k) Report

FDA applicant

Syn-Kit, Inc.

Mchenry, IL34 decisions1980–19860 recalls

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, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

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.

FIG. 1 — Syn-Kit, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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