The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Dart Alpha-amylase Reagent System.
| Device ID | K834053 |
| 510k Number | K834053 |
| Device Name: | DART ALPHA-AMYLASE REAGENT SYSTEM |
| Classification | Saccharogenic, Amylase |
| Applicant | COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-23 |
| Decision Date | 1984-02-04 |