HYDRO-SIL(TM) COATED GUIDEWIRES
Device Facts
| Record ID | K900822 |
|---|---|
| Device Name | HYDRO-SIL(TM) COATED GUIDEWIRES |
| Applicant | National-Standard Medical Products |
| Product Code | DOX · Clinical Toxicology |
| Decision Date | Jul 17, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3550 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.
