The following data is part of a premarket notification filed by Bg Medicine, Inc. with the FDA for Bgm Galectin -3.
| Device ID | K093758 |
| 510k Number | K093758 |
| Device Name: | BGM GALECTIN -3 |
| Classification | Galectin-3 In Vitro Diagnostic Assay |
| Applicant | BG MEDICINE, INC. 610N LINCOLN ST. Waltham, MA 02451 |
| Contact | Carol Adiletto |
| Correspondent | Carol Adiletto BG MEDICINE, INC. 610N LINCOLN ST. Waltham, MA 02451 |
| Product Code | OSX |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-07 |
| Decision Date | 2010-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867444000207 | K093758 | 000 |