← Product Code [GGQ](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGQ) · K800656

# A-GENT QUANTICHROM THROMBIGEN-E (K800656)

_Abbott Laboratories · GGQ · May 30, 1980 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGQ/K800656

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [GGQ](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGQ.md)
- **Decision Date:** May 30, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7720
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A prothrombin consumption tests is a device that measures the patient's capacity to generate thromboplastin in the coagulation process. The test also is an indirect indicator of qualitative or quantitative platelet abnormalities. It is a screening test for thrombocytopenia (decreased number of blood platelets) and hemophilia A and B.

## Special Controls

*Classification.* Class II (special controls). The device 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/GGQ/K800656](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGQ/K800656)

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