EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL
Device Facts
| Record ID | K002974 |
|---|---|
| Device Name | EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL |
| Applicant | Dade Behring, Inc. |
| Product Code | LDP · Clinical Toxicology |
| Decision Date | Oct 11, 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.
