The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Model 115-16 Phosphorus (uv) Assay Kit.
| Device ID | K862834 |
| 510k Number | K862834 |
| Device Name: | MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT |
| Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| 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 | CEO |
| CFR Regulation Number | 862.1580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-25 |
| Decision Date | 1986-08-19 |