The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Hsv-2 Type Specific Igg Assay, Control Hsv-2 Igg.
Device ID | K081687 |
510k Number | K081687 |
Device Name: | LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG |
Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 |
Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
Contact | Carol A Depouw |
Correspondent | Carol A Depouw DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
Product Code | MYF |
CFR Regulation Number | 866.3305 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-17 |
Decision Date | 2008-11-10 |
Summary: | summary |