The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Chem 1 Sys Analytes Magnesium Ggt, Uric.
| Device ID | K853853 |
| 510k Number | K853853 |
| Device Name: | TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC |
| Classification | Photometric Method, Magnesium |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Leonard A Dwarica |
| Correspondent | Leonard A Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | JGJ |
| CFR Regulation Number | 862.1495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-16 |
| Decision Date | 1985-10-03 |