← Product Code [CEW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW) · K896294

# DSL I-PTH (DSL #8000) (K896294)

_Diagnostic Systems Laboratories, Inc. · CEW · Nov 21, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW/K896294

## Device Facts

- **Applicant:** Diagnostic Systems Laboratories, Inc.
- **Product Code:** [CEW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW.md)
- **Decision Date:** Nov 21, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1545
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW/K896294](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW/K896294)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com