← Product Code [GGN](/productcode/GGN) · K884854

# COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL) (K884854)

_Precision Biologicals, Inc. · GGN · Jan 30, 1989 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K884854

## Device Facts

- **Applicant:** Precision Biologicals, Inc.
- **Product Code:** [GGN](/productcode/GGN.md)
- **Decision Date:** Jan 30, 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/device/K884854](https://fda.innolitics.com/device/K884854)

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