510(k) K050755
- Device
- MODIFICATION TO BVBLUE
- Applicant
- GRYPHUS DIAGNOSTICS, LLC
- 510(k) number
- K050755
- Product code
- MXB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-04-06
- Date received
- 2005-03-23
- Regulation
- 866.2660
- Classification name
- Test, Vaginal, Bacterial Sialidase
- Medical specialty
- Microbiology
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS M TSAKERIS
- Address
- 16809 Briardale Rd. Rockville MD US 20855 20855
FDA Registration Numbers#
- 3020139194
- 2030538
- 3042854290
- 2029372
- 3006546675
- 3015209536
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MXB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993732 | BVBLUE | Gryphus Diagnostics, LLC | 2000-05-15 |
Legacy Summary#
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FDA Review#
Decision Summary