The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Rubella Igm, Liaison Control Rubella Igm.
Device ID | K122397 |
510k Number | K122397 |
Device Name: | LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM |
Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
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 | LFX |
CFR Regulation Number | 866.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-08-07 |
Decision Date | 2012-09-06 |
Summary: | summary |