The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Axon System Reagent Methods.
| Device ID | K900905 |
| 510k Number | K900905 |
| Device Name: | TECHNICON AXON SYSTEM REAGENT METHODS |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | C Brewster |
| Correspondent | C Brewster TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-27 |
| Decision Date | 1990-04-03 |