FDA applicant
Kleen Test Products
FDA records 17 decisions for Kleen Test Products (Mchenry, IL) from 1976 to 1989: 17 510(k) clearances. Most are in product codes BXX (Calibrator, Pressure, Gas) and MMK (Container, Sharps). 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 Kleen Test Products’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Kleen Test Products since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Kleen Test Products’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