ATS NAC-PAC SET
Device Facts
| Record ID | K881949 |
|---|---|
| Device Name | ATS NAC-PAC SET |
| Applicant | Alpha-Tec Systems, Inc. |
| Product Code | JSK · Microbiology |
| Decision Date | May 25, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2450 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A supplement for culture media is a device, such as a vitamin or sugar mixture, that is added to a solid or liquid basal culture medium to produce a desired formulation and that is intended for medical purposes to enhance the growth of fastidious microorganisms (those having complex nutritional requirements). This device aids in the diagnosis of diseases caused by pathogenic microorganisms.
