The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Axon(tm) System.
| Device ID | K885226 |
| 510k Number | K885226 |
| Device Name: | TECHNICON AXON(TM) SYSTEM |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | A Dwarica |
| Correspondent | A Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-20 |
| Decision Date | 1989-02-17 |