AUTOMATED ELISA READER LBI 300
Device Facts
| Record ID | K830227 |
|---|---|
| Device Name | AUTOMATED ELISA READER LBI 300 |
| Applicant | Bionetic Laboratory Products |
| Product Code | JTQ · Microbiology |
| Decision Date | Mar 10, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2540 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A microbiological incubator is a device with various chambers or water-filled compartments in which controlled environmental conditions, particularly temperature, are maintained. It is intended for medical purposes to cultivate microorganisms and aid in the diagnosis of disease.
