MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE
Device Facts
| Record ID | K872230 |
|---|---|
| Device Name | MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE |
| Applicant | Intermedics, Inc. |
| Product Code | DBT · Immunology |
| Decision Date | Sep 15, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5330 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A factor XIII, A, S, immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the factor XIII (a bloodclotting factor), in platelets (A) or serum (S). Measurements of factor XIII, A, S, aid in the diagnosis and treatment of certain bleeding disorders resulting from a deficiency of this factor.
