The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Diamedix Is-ana Elisa Screen Test System.
| Device ID | K993294 |
| 510k Number | K993294 |
| Device Name: | DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM |
| Classification | Antinuclear Antibody, Antigen, Control |
| Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Contact | Lynne Stirling, Ph.d |
| Correspondent | Lynne Stirling, Ph.d DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Product Code | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-01 |
| Decision Date | 1999-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817273020396 | K993294 | 000 |