← Product Code [JKP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKP) · K810762

# API TURBICITY STANDARD (K810762)

_Analytical Products, Inc. · JKP · Apr 3, 1981 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKP/K810762

## Device Facts

- **Applicant:** Analytical Products, Inc.
- **Product Code:** [JKP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKP.md)
- **Decision Date:** Apr 3, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1130
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A blood volume test system is a device intended to measure the circulating blood volume. Blood volume measurements are used in the diagnosis and treatment of shock, hemorrhage, and polycythemia vera (a disease characterized by an absolute increase in erythrocyte mass and total blood volume).

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKP/K810762](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKP/K810762)

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