The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Axon Tm System Additional Analytes.
| Device ID | K892929 |
| 510k Number | K892929 |
| Device Name: | TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES |
| Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Leonard Dwarica |
| Correspondent | Leonard Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | CHJ |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-21 |
| Decision Date | 1989-07-20 |