The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Ra(r) Systems & Assist(r) Clin. Analyzer.
| Device ID | K871892 |
| 510k Number | K871892 |
| Device Name: | TECHNICON RA(R) SYSTEMS & ASSIST(R) CLIN. ANALYZER |
| Classification | Acid, Uric, Uricase (colorimetric) |
| 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 | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-15 |
| Decision Date | 1987-06-17 |