FDA applicant
Alfa Wassermann Diagnostics Technologies, LLC
FDA records 3 decisions for Alfa Wassermann Diagnostics Technologies, LLC (West Caldwell, NJ) from 2012 to 2013: 3 510(k) clearances. Most are in product codes CIX (Bromcresol Green Dye-Binding, Albumin) and CDN (Urease, Photometric, Urea Nitrogen). Its devices cite 5 predicates, 0 of them its own earlier devices. 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 Alfa Wassermann Diagnostics Technologies, LLC’s devices, and how often a recall has named them.
FDA decisions per year
2in 2013
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Alfa Wassermann Diagnostics…’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) ReportOther applicant names beginning “Alfa”
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