The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Thyroxine Microassay.
| Device ID | K884260 |
| 510k Number | K884260 |
| Device Name: | THYROXINE MICROASSAY |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Contact | Kiefer, Phd |
| Correspondent | Kiefer, Phd DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Product Code | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-11 |
| Decision Date | 1989-02-23 |