ASSAY STRIPS
Device Facts
| Record ID | K803244 |
|---|---|
| Device Name | ASSAY STRIPS |
| Applicant | Corning Costar Corp. |
| Product Code | JTC · Microbiology |
| Decision Date | Feb 2, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2500 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A microtiter diluting and dispensing device is a mechanical device intended for medical purposes to dispense or serially dilute very small quantities of biological or chemical reagents for use in various diagnostic procedures.