← Product Code [JKA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA) · K880594

# VACUGUARD(TM) (K880594)

_Habley Medical Technology Corp. · JKA · Apr 28, 1988 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA/K880594

## Device Facts

- **Applicant:** Habley Medical Technology Corp.
- **Product Code:** [JKA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA.md)
- **Decision Date:** Apr 28, 1988
- **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/JKA/K880594](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA/K880594)

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