510(k) K050755
K050755 is an FDA 510(k) premarket notification submitted by Gryphus Diagnostics, LLC for the device "MODIFICATION TO BVBLUE". The FDA issued a decision of Substantially Equivalent on April 6, 2005. The device falls under product code MXB (Test, Vaginal, Bacterial Sialidase), a Class I device regulated under 21 CFR 866.2660. Gryphus Diagnostics, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2005
- Date Received
- March 23, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Vaginal, Bacterial Sialidase
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- CH
- Submission Type