T9000 TSB 10ML
Device Facts
| Record ID | K870593 |
|---|---|
| Device Name | T9000 TSB 10ML |
| Applicant | Lakewood Biochemical Co., Inc. |
| Product Code | JSG · Microbiology |
| Decision Date | Mar 30, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2300 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A multipurpose culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes for the cultivation and identification of several types of pathogenic microorganisms without the need of additional nutritional supplements. Test results aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these microorganisms.
