FDA applicant
Clinical Diagnostic Solutions, Inc.
FDA records 3 decisions for Clinical Diagnostic Solutions, Inc. (Plantation, FL) from 1999 to 2004: 3 510(k) clearances. Most are in product codes JPK (Mixture, Hematology Quality Control) and KRX (Calibrator For Cell Indices). 7 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Clinical Diagnostic Solutions, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Clinical Diagnostic Solutions, Inc. since 2007.
Recalls per year
1in 2013
Class I Class II/III not classified
Planning a device like Clinical Diagnostic Solutions, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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