The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Diamedix Is-cmv Igm Capture Test System.
| Device ID | K001767 |
| 510k Number | K001767 |
| Device Name: | DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM |
| Classification | Antigen, Iha, Cytomegalovirus |
| 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 | LJO |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-12 |
| Decision Date | 2000-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817273020167 | K001767 | 000 |
| 00817273020020 | K001767 | 000 |
| 00817273020013 | K001767 | 000 |