The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Technicon H* 3tm Rtc System (in-vitro Diag.syst.).
| Device ID | K930685 |
| 510k Number | K930685 |
| Device Name: | TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca |
| Correspondent | Gabriel J Muraca HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-10 |
| Decision Date | 1993-06-22 |