The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Diamedix Is-anti-b2 Glycoprotein I Screen.
Device ID | K013956 |
510k Number | K013956 |
Device Name: | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN |
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 | 2001-11-30 |
Decision Date | 2002-01-08 |
Summary: | summary |