The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Diamedix Is-anti-cardiolipin Screen Test System.
Device ID | K012053 |
510k Number | K012053 |
Device Name: | DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM |
Classification | System, Test, Anticardiolipin Immunological |
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 | MID |
CFR Regulation Number | 866.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-02 |
Decision Date | 2001-08-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817273020297 | K012053 | 000 |