The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Chem 1 Clinical Analyzer Urine Urea Nitrogen.
| Device ID | K901123 |
| 510k Number | K901123 |
| Device Name: | CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| 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 | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-12 |
| Decision Date | 1990-05-10 |