The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Immuno I(tm) System And Analytes.
| Device ID | K902243 |
| 510k Number | K902243 |
| Device Name: | TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Brewster, Phd |
| Correspondent | Brewster, Phd TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-18 |
| Decision Date | 1990-07-05 |