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 |