← Product Code [GIZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ) · K895262

# NORMAL COAGULATION CONTROL PLASMA (NCCP) (K895262)

_Medical Diagnostic Technologies, Inc. · GIZ · Oct 6, 1989 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K895262

## Device Facts

- **Applicant:** Medical Diagnostic Technologies, Inc.
- **Product Code:** [GIZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ.md)
- **Decision Date:** Oct 6, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5425
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

## Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K895262](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K895262)

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