← Product Code [JMF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMF) · K802454

# GESTE FOLLOW KIT DETERM. OF HPL (K802454)

_Syn-Kit, Inc. · JMF · Nov 12, 1980 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JMF/K802454

## Device Facts

- **Applicant:** Syn-Kit, Inc.
- **Product Code:** [JMF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMF.md)
- **Decision Date:** Nov 12, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1585
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A human placental lactogen test system is a device intended to measure the hormone human placental lactogen (HPL), (also known as human chorionic somatomammotrophin (HCS)), in maternal serum and maternal plasma. Measurements of human placental lactogen are used in the diagnosis and clinical management of high-risk pregnancies involving fetal distress associated with placental insufficiency. Measurements of HPL are also used in pregnancies complicated by hypertension, proteinuria, edema, post-maturity, placental insufficiency, or possible miscarriage.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JMF/K802454](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JMF/K802454)

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