← Product Code [MDB](/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB) · K921133

# BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA (K921133)

_Bd Becton Dickinson Vacutainer Systems Preanalytic · MDB · Apr 22, 1992 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB/K921133

## Device Facts

- **Applicant:** Bd Becton Dickinson Vacutainer Systems Preanalytic
- **Product Code:** [MDB](/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB.md)
- **Decision Date:** Apr 22, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2560
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB/K921133](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB/K921133)

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