← Product Code [MSJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ) · K851641

# THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL (K851641)

_Ortho Diagnostic Systems, Inc. · MSJ · Jul 23, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ/K851641

## Device Facts

- **Applicant:** Ortho Diagnostic Systems, Inc.
- **Product Code:** [MSJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ.md)
- **Decision Date:** Jul 23, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1475
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ/K851641](https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ/K851641)

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