ACETAMINOPHEN ASSAY
Device Facts
| Record ID | K952949 |
|---|---|
| Device Name | ACETAMINOPHEN ASSAY |
| Applicant | Diagnostic Chemicals , Ltd. |
| Product Code | LDP · Clinical Toxicology |
| Decision Date | Sep 6, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3030 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.
