ABUSCREEN ONLINE(R) CALIBRATORS
Device Facts
| Record ID | K946000 |
|---|---|
| Device Name | ABUSCREEN ONLINE(R) CALIBRATORS |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | DKJ · Clinical Toxicology |
| Decision Date | Jan 25, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3830 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.
