The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Technicon H*2.
| Device ID | K923237 |
| 510k Number | K923237 |
| Device Name: | TECHNICON H*2 |
| Classification | Counter, Differential Cell |
| Applicant | HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Robert L Habig |
| Correspondent | Robert L Habig HERAEUS KULZER, 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 | 1992-07-02 |
| Decision Date | 1992-09-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TECHNICON H*2 74358976 1800570 Dead/Cancelled |
BAYER CORPORATION 1993-02-16 |