The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Chem-link Data Base Manager.
| Device ID | K912413 |
| 510k Number | K912413 |
| Device Name: | CHEM-LINK DATA BASE MANAGER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| 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 | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-31 |
| Decision Date | 1991-07-01 |