The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Is-toxoplasma Igg Test System.
Device ID | K981498 |
510k Number | K981498 |
Device Name: | IS-TOXOPLASMA IGG TEST SYSTEM |
Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
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 | LGD |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-04-27 |
Decision Date | 1998-08-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817273020136 | K981498 | 000 |
B3507203000 | K981498 | 000 |