The following data is part of a premarket notification filed by Miles, Inc. with the FDA for Technicon H* 3 Rtc System (in-vitro Diagnostic System).
| Device ID | K941171 |
| 510k Number | K941171 |
| Device Name: | TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) |
| Classification | Counter, Differential Cell |
| 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 | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-14 |
| Decision Date | 1994-12-14 |