The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Testpoint(tm) Ligand Control.
| Device ID | K900717 |
| 510k Number | K900717 |
| Device Name: | TECHNICON TESTPOINT(TM) LIGAND CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | C Brewster |
| Correspondent | C Brewster TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-14 |
| Decision Date | 1990-04-26 |