The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Model 303-47/303-48 Alanine Aminotransferase Kit.
| Device ID | K862833 |
| 510k Number | K862833 |
| Device Name: | MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| 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 | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-25 |
| Decision Date | 1986-08-19 |