MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
Device Facts
| Record ID | K011145 |
|---|---|
| Device Name | MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 |
| Applicant | Roche Diagnostics Corp. |
| Product Code | JFJ · Clinical Chemistry |
| Decision Date | Jun 25, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1070 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
