The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Axon(tm) System Methods Anyalye Hdl Chol.
| Device ID | K914511 |
| 510k Number | K914511 |
| Device Name: | TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| 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 | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-09 |
| Decision Date | 1991-11-27 |