The following data is part of a premarket notification filed by Miles, Inc. with the FDA for Iron -ii (fe-ii) Method/tech Chem 1(r) 1+tm System.
| Device ID | K935287 |
| 510k Number | K935287 |
| Device Name: | IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | MILES, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca |
| Correspondent | Gabriel J Muraca MILES, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-03 |
| Decision Date | 1994-01-03 |