The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Diasorin Liaison Treponema Assay.
Device ID | K061247 |
510k Number | K061247 |
Device Name: | DIASORIN LIAISON TREPONEMA ASSAY |
Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
Contact | Carol A Depouw |
Correspondent | Carol A Depouw DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
Product Code | LIP |
CFR Regulation Number | 866.3830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-03 |
Decision Date | 2006-07-31 |
Summary: | summary |