← Product Code [DHA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/DHA) · K922073

# STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY (K922073)

_Baxter Diagnostics, Inc. · DHA · Oct 19, 1992 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/DHA/K922073

## Device Facts

- **Applicant:** Baxter Diagnostics, Inc.
- **Product Code:** [DHA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/DHA.md)
- **Decision Date:** Oct 19, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1155
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/DHA/K922073](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/DHA/K922073)

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