← Product Code [LGP](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LGP) · K803110

# PROTEOLYTIC ENZYME CONTROL (K803110)

_American Dade · LGP · Feb 17, 1981 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LGP/K803110

## Device Facts

- **Applicant:** American Dade
- **Product Code:** [LGP](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LGP.md)
- **Decision Date:** Feb 17, 1981
- **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/CH/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LGP/K803110](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LGP/K803110)

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