SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
Device Facts
| Record ID | K000494 |
|---|---|
| Device Name | SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT |
| Applicant | Beckman Coulter, Inc. |
| Product Code | LDP · Clinical Toxicology |
| Decision Date | Apr 14, 2000 |
| 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.
