The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon H*1 System (hdw).
| Device ID | K853030 |
| 510k Number | K853030 |
| Device Name: | TECHNICON H*1 SYSTEM (HDW) |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Leonard A Dwarica |
| Correspondent | Leonard A Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-18 |
| Decision Date | 1986-02-05 |