← Product Code [GJA](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA) · K862301

# IL SYSTEM 810, ACL AND THE REAGENT SETS (K862301)

_Instrumentation Laboratory CO · GJA · Sep 3, 1986 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K862301

## Device Facts

- **Applicant:** Instrumentation Laboratory CO
- **Product Code:** [GJA](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA.md)
- **Decision Date:** Sep 3, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7875
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K862301](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K862301)

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