← Product Code [GIS](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GIS) · K881150

# KINETIC FIBRINOGEN ASSAY (K881150)

_Bio/Data Corp. · GIS · Mar 28, 1988 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GIS/K881150

## Device Facts

- **Applicant:** Bio/Data Corp.
- **Product Code:** [GIS](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GIS.md)
- **Decision Date:** Mar 28, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7340
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

## Special Controls

*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system 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-h%E2%80%94hematology-kits-and-packages/GIS/K881150](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GIS/K881150)

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