The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Diamedix Is-rf Test System.
Device ID | K974889 |
510k Number | K974889 |
Device Name: | DIAMEDIX IS-RF 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 | 1997-12-30 |
Decision Date | 1998-03-06 |
Summary: | summary |