The following data is part of a premarket notification filed by Miles, Inc. with the FDA for Creatinine (enzymatic Uv) Procedure For Technicon Systems (in Vitro Diagnostic Test System).
| Device ID | K945655 |
| 510k Number | K945655 |
| Device Name: | CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM) |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | MILES, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca Jr |
| Correspondent | Gabriel J Muraca Jr MILES, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-17 |
| Decision Date | 1995-01-05 |