The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Borrelia Igg/igm Assay, Model 310870; Serum Controls, Model 310871.
Device ID | K062473 |
510k Number | K062473 |
Device Name: | LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871 |
Classification | Reagent, Borrelia Serological Reagent |
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 | LSR |
CFR Regulation Number | 866.3830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-24 |
Decision Date | 2007-04-12 |
Summary: | summary |