The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Axon(tm) Systems, Alt(p 5-p)/ast(p 5-p).
| Device ID | K914025 |
| 510k Number | K914025 |
| Device Name: | TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Thomas C Brewster |
| Correspondent | Thomas C Brewster TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-09 |
| Decision Date | 1991-11-22 |