STAT/PB REAGENT
Device Facts
| Record ID | K843839 |
|---|---|
| Device Name | STAT/PB REAGENT |
| Applicant | Tri-Tech, Inc. |
| Product Code | DOF · Clinical Toxicology |
| Decision Date | Jan 3, 1985 |
| 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.
