The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon H*1 System.
| Device ID | K842636 |
| 510k Number | K842636 |
| Device Name: | TECHNICON H*1 SYSTEM |
| Classification | Counter, Differential Cell |
| Applicant | TECHNICON INSTRUMENTS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-09 |
| Decision Date | 1984-07-27 |