The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Diamedix Is-anti-b2 Glycoprotein I Igg/igm Test System.
| Device ID | K013628 |
| 510k Number | K013628 |
| Device Name: | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| 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 | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-05 |
| Decision Date | 2001-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817273020402 | K013628 | 000 |