The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Jas Amylase Liquid Reagent.
| Device ID | K020282 |
| 510k Number | K020282 |
| Device Name: | JAS AMYLASE LIQUID REAGENT |
| Classification | Catalytic Methods, Amylase |
| Applicant | JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Contact | David Johnson |
| Correspondent | David Johnson JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-28 |
| Decision Date | 2002-02-28 |