← Product Code [JBP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP) · K002528

# SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION (K002528)

_Sienco, Inc. · JBP · Aug 31, 2000 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K002528

## Device Facts

- **Applicant:** Sienco, Inc.
- **Product Code:** [JBP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP.md)
- **Decision Date:** Aug 31, 2000
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 864.7140
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K002528](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K002528)

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