BVBLUE
FDA 510(k) clearance K993732 · decided 2000-05-15
Clearance details
- K-number
- K993732
- Device name
- BVBLUE
- Applicant
- Gryphus Diagnostics, LLC
- Decision
- Substantially Equivalent
- Date received
- 1999-11-04
- Decision date
- 2000-05-15
- Days to decision
- 193 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| MODIFICATION TO BVBLUE (K050755) | Gryphus Diagnostics, LLC | 2005-04-06 |
Recalls involving this device
No recalls on record reference this clearance.