← Product Code [DHI](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHI) · K810625

# HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- (K810625)

_Serono Laboratories, Inc. · DHI · Mar 27, 1981 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DHI/K810625

## Device Facts

- **Applicant:** Serono Laboratories, Inc.
- **Product Code:** [DHI](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHI.md)
- **Decision Date:** Mar 27, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5065
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A human allotypic marker immunological test system is a device that consists of the reagents used to identify by immunochemical techniques the inherited human protein allotypic markers (such as nGm, nA2 m, and Km allotypes) in serum and other body fluids. The identification may be used while studying population genetics.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DHI/K810625](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DHI/K810625)

**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