Nephelometric, Amylase
FDA product code KHM · Class II (moderate risk) · 21 CFR 862.1070 · Clinical Chemistry
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831295 | Amylase Reagent #88129KHM · Traditional | Hi Chem, Inc. | 06/30/1983SE |
| K812699 | AmylaseKHM · Traditional | Pointe Scientific, Inc., | 10/06/1981SE |
| K812447 | Amylase Reagent KitKHM · Traditional | Bioscientific | 09/09/1981SE |
| K801096 | Perkin Elmer Model 91 Amylase ReagentKHM · Traditional | Stat Engineering | 06/09/1980SE |
| K790797 | Amylase Reagent SetKHM · Traditional | Alta Diagnostics, Inc. | 07/17/1979SE |
| K770400 | Reagent, Amylase LipaseKHM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/26/1977SE |