← Product Code [CBT](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT) · K801435

# ORGANON ARTERIAL BLOOD SAMPLER (K801435)

_Akzona, Inc. · CBT · Jul 18, 1980 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K801435

## Device Facts

- **Applicant:** Akzona, Inc.
- **Product Code:** [CBT](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT.md)
- **Decision Date:** Jul 18, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1100
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K801435](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K801435)

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