The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Ra Systems Gentamicin Test Method.
| Device ID | K893912 |
| 510k Number | K893912 |
| Device Name: | TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD |
| Classification | Enzyme Immunoassay, Gentamicin |
| 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 | LCD |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-30 |
| Decision Date | 1989-08-21 |