EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
Device Facts
| Record ID | K954933 |
|---|---|
| Device Name | EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN |
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc. |
| Product Code | LDP · Clinical Toxicology |
| Decision Date | Dec 18, 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.
