MODIFICATION TO BVBLUE
FDA 510(k) clearance K050755 · decided 2005-04-06
Clearance details
- K-number
- K050755
- Device name
- MODIFICATION TO BVBLUE
- Applicant
- Gryphus Diagnostics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-03-23
- Decision date
- 2005-04-06
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- MXB
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BVBLUE (K993732) | Gryphus Diagnostics, LLC | 2000-05-15 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sekisui Diagnostics Control Kit OSOM BVBLUE Bacterial Vaginosis recall (Z-1311-2024) | Mckesson Medical-Surgical Inc. Corporate Office | 2024-03-19 |