The following data is part of a premarket notification filed by Miles, Inc. with the FDA for Technicon H* 2 System, Labfacts Software For U.i.w. Versions 4.11 & 5.11.
| Device ID | K933475 |
| 510k Number | K933475 |
| Device Name: | TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 |
| Classification | Counter, Differential Cell |
| 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 | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-16 |
| Decision Date | 1993-11-22 |