The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Amylase 405 Catalog Number 301-34.
| Device ID | K880867 |
| 510k Number | K880867 |
| Device Name: | AMYLASE 405 CATALOG NUMBER 301-34 |
| Classification | Catalytic Methods, Amylase |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
| Contact | David Templeton |
| Correspondent | David Templeton DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-01 |
| Decision Date | 1988-04-19 |