AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)
Device Facts
| Record ID | K951494 |
|---|---|
| Device Name | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) |
| Applicant | Emd Chemicals, Inc. |
| Product Code | CIJ · Clinical Chemistry |
| Decision Date | Dec 11, 1995 |
| 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).
