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 |