← Product Code [KHE](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE) · K840904

# ACCU-CULT FECAL OCCULT BLOOD TEST (K840904)

_Applied Medical Devices, Inc. · KHE · Aug 16, 1984 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K840904

## Device Facts

- **Applicant:** Applied Medical Devices, Inc.
- **Product Code:** [KHE](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE.md)
- **Decision Date:** Aug 16, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.6550
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

## Special Controls

*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K840904](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K840904)

**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