The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon H*2(tm) System.
| Device ID | K900593 |
| 510k Number | K900593 |
| Device Name: | TECHNICON H*2(TM) SYSTEM |
| Classification | Counter, Differential Cell |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | C Brewster |
| Correspondent | C Brewster TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-07 |
| Decision Date | 1990-03-14 |