← Product Code MTF · P850048

# TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048)

_Beckman Coulter, Inc. · MTF · Feb 25, 1986 · Immunology · APPR_

**Canonical URL:** https://fda.innolitics.com/device/P850048

## Device Facts

- **Applicant:** Beckman Coulter, Inc.
- **Product Code:** MTF
- **Decision Date:** Feb 25, 1986
- **Decision:** APPR
- **Device Class:** Class 3
- **Review Panel:** Immunology

---

**Source:** [https://fda.innolitics.com/device/P850048](https://fda.innolitics.com/device/P850048)

**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 PMA](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [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