The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Ammonia Assay Cat. No. 200-02.
| Device ID | K932556 |
| 510k Number | K932556 |
| Device Name: | AMMONIA ASSAY CAT. NO. 200-02 |
| Classification | Enzymatic Method, Ammonia |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Product Code | JIF |
| CFR Regulation Number | 862.1065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-26 |
| Decision Date | 1994-08-02 |