The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Infinity Amylase Reagent (procedure No. 580/568).
| Device ID | K001569 |
| 510k Number | K001569 |
| Device Name: | INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) |
| Classification | Catalytic Methods, Amylase |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | William R Gilbert |
| Correspondent | William R Gilbert SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-19 |
| Decision Date | 2000-06-26 |