Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Sienco, Inc. with 6 510(k) clearances. The most recent is a 510(k) clearance dated Oct 27, 2026: Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1); So….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 27, 2026 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1); Sonoclot Coagulation & Platelet Function Analzyer System with Sonoclot Viewer (SCP2); Sonoclot Coagulation Analyzer System with Sonoclot Viewer (SC1)K260909 · JPA | 510(k) clearances |
| Jan 4, 2023 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerK223635 · JBP | 510(k) clearances |
| Dec 12, 2003 | AIACT KITK032952 · JBP | 510(k) clearances |
| Aug 31, 2000 | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTIONK002528 · JBP | 510(k) clearances |
| May 28, 1999 | GBACT + KITK984141 · JBP | 510(k) clearances |
| Sep 5, 1995 | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZERK952560 · JPA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
