← Product Code [GKB](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKB) · K892522

# SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED (K892522)

_Gespac, Inc. · GKB · May 24, 1989 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKB/K892522

## Device Facts

- **Applicant:** Gespac, Inc.
- **Product Code:** [GKB](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKB.md)
- **Decision Date:** May 24, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5800
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

An automated sedimentation rate device is an instrument that measures automatically the erythrocyte sedimentation rate in whole blood. Because an increased sedimentation rate indicates tissue damage or inflammation, the erythrocyte sedimentation rate device is useful in monitoring treatment of a disease.

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKB/K892522](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKB/K892522)

**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