The following data is part of a premarket notification filed by Sebia with the FDA for Minicap Immunotyping, Model: 2300.
Device ID | K082388 |
510k Number | K082388 |
Device Name: | MINICAP IMMUNOTYPING, MODEL: 2300 |
Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
Applicant | SEBIA 400-1705 CORPORATE DRIVE Norcross, GA 30093 |
Contact | Karen Anderson |
Correspondent | Karen Anderson SEBIA 400-1705 CORPORATE DRIVE Norcross, GA 30093 |
Product Code | CFF |
Subsequent Product Code | CEF |
Subsequent Product Code | DEH |
Subsequent Product Code | DFH |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-08-19 |
Decision Date | 2009-04-14 |