BACT/ALERT (TM)
Device Facts
| Record ID | K903505 |
|---|---|
| Device Name | BACT/ALERT (TM) |
| Applicant | Organon Teknika Corp. |
| Product Code | MDB · Microbiology |
| Decision Date | Mar 12, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2560 |
| Device Class | Class 1 |
Regulatory Classification
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.
