The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Diamedix Is-hsv 1&2 Igm Test System.
Device ID | K002262 |
510k Number | K002262 |
Device Name: | DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM |
Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
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 | LGC |
CFR Regulation Number | 866.3305 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-25 |
Decision Date | 2000-11-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817273020181 | K002262 | 000 |
B3507203500 | K002262 | 000 |