The following data is part of a premarket notification filed by Sebia with the FDA for Gelscan, Model 1206.
Device ID | K100307 |
510k Number | K100307 |
Device Name: | GELSCAN, MODEL 1206 |
Classification | Electrophoretic, Lactate Dehydrogenase Isoenzymes |
Applicant | SEBIA 1705 CORPORATE DRIVE SUITE 400 Norcross, GA 30093 |
Contact | Karen Anderson |
Correspondent | Karen Anderson SEBIA 1705 CORPORATE DRIVE SUITE 400 Norcross, GA 30093 |
Product Code | CFE |
Subsequent Product Code | CIN |
Subsequent Product Code | JHY |
Subsequent Product Code | JQT |
CFR Regulation Number | 862.1445 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-02-03 |
Decision Date | 2010-08-31 |