510(k) K093758
- Device
- BGM GALECTIN -3
- Applicant
- BG MEDICINE, INC.
- 510(k) number
- K093758
- Product code
- OSX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-11-17
- Date received
- 2009-12-07
- Regulation
- 862.1117
- Classification name
- Galectin-3 In Vitro Diagnostic Assay
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Carol Adiletto
- Address
- 610n Lincoln St. Waltham MA US 02451 02451
FDA Registration Numbers#
- 1721937
- 2521625
- 3002809144
- 3005333358
Source Documents#
Other 510(k) Records For Product Code OSX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140436 | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS | Fujirebio Diagnostics,Inc. | 2014-12-23 |
Legacy Summary#
summary
FDA Review#
Decision Summary