POLY-LEC SYSTEM
Device Facts
| Record ID | K792582 |
|---|---|
| Device Name | POLY-LEC SYSTEM |
| Applicant | Gamma Biologicals, Inc. |
| Product Code | KSI · Hematology |
| Decision Date | Jan 16, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.9550 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Lectins and protectins are proteins derived from plants and lower animals that cause cell agglutination in the presence of certain antigens. These substances are used to detect blood group antigens for in vitro diagnostic purposes.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
