The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Diamedix Is-rubella Igm Capture Test System.
| Device ID | K001875 |
| 510k Number | K001875 |
| Device Name: | DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| 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 | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-20 |
| Decision Date | 2000-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817273020211 | K001875 | 000 |
| 00817273020204 | K001875 | 000 |