← Product Code [JCA](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JCA) · K871318

# Q.I.C. BLEEDING TIME DEVICE (K871318)

_Helena Laboratories · JCA · Jun 10, 1987 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JCA/K871318

## Device Facts

- **Applicant:** Helena Laboratories
- **Product Code:** [JCA](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JCA.md)
- **Decision Date:** Jun 10, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.6100
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A bleeding time device is a device, usually employing two spring-loaded blades, that produces two small incisions in the patient's skin. The length of time required for the bleeding to stop is a measure of the effectiveness of the coagulation system, primarily the platelets.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JCA/K871318](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JCA/K871318)

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