The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Hybritech Data Station.
| Device ID | K834300 |
| 510k Number | K834300 |
| Device Name: | HYBRITECH DATA STATION |
| Classification | Calculator/data Processing Module, For Clinical Use |
| Applicant | HYBRITECH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JQP |
| CFR Regulation Number | 862.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-09 |
| Decision Date | 1984-02-21 |