The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for X-amylase Assay Kit.
| Device ID | K852636 |
| 510k Number | K852636 |
| Device Name: | X-AMYLASE ASSAY KIT |
| Classification | Saccharogenic, Amylase |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Contact | Callbeck R.t. |
| Correspondent | Callbeck R.t. DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Product Code | CIJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-20 |
| Decision Date | 1985-07-12 |