The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Diamedix Is-rheumatoid Factor Test System.
| Device ID | K021394 |
| 510k Number | K021394 |
| Device Name: | DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Contact | Lynne Stirling |
| Correspondent | Lynne Stirling DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-02 |
| Decision Date | 2002-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817273020389 | K021394 | 000 |
| B3507207100 | K021394 | 000 |