← Product Code [GIM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/GIM) · K861449

# VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE) (K861449)

_Exel Intl. · GIM · Sep 16, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/GIM/K861449

## Device Facts

- **Applicant:** Exel Intl.
- **Product Code:** [GIM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/GIM.md)
- **Decision Date:** Sep 16, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1675
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/GIM/K861449](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/GIM/K861449)

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