← Product Code [JKA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA) · K831719

# MONOJET SPS BLOOD COLLECTION TUBE (K831719)

_Sherwood Medical Co. · JKA · Jul 18, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA/K831719

## Device Facts

- **Applicant:** Sherwood Medical Co.
- **Product Code:** [JKA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA.md)
- **Decision Date:** Jul 18, 1983
- **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/K831719](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA/K831719)

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