← Product Code [GKP](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP) · K931206

# ELECTRA 1600C AUTOMATIC COAGULATION TIMER (K931206)

_Medical Laboratory Automation Systems, Inc. · GKP · Aug 23, 1993 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K931206

## Device Facts

- **Applicant:** Medical Laboratory Automation Systems, Inc.
- **Product Code:** [GKP](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP.md)
- **Decision Date:** Aug 23, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5400
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

## Special Controls

*Classification.* Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument 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/GKP/K931206](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K931206)

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