SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
Device Facts
| Record ID | K011465 |
|---|---|
| Device Name | SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO |
| Applicant | Beckman Coulter, Inc. |
| Product Code | LDP · Clinical Toxicology |
| Decision Date | Jun 8, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.
