← Product Code [JBX](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX) · K862775

# ASSERACHROM B-TG KIT (K862775)

_American Bioproducts Co. · JBX · Oct 22, 1986 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX/K862775

## Device Facts

- **Applicant:** American Bioproducts Co.
- **Product Code:** [JBX](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX.md)
- **Decision Date:** Oct 22, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.6675
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A platelet aggregometer is a device, used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet rich plasma.

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX/K862775](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX/K862775)

**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
