BD MAX CTGCTV2, BD MAX System
FDA 510(k) clearance K182692 · decided 2019-01-08
Clearance details
- K-number
- K182692
- Device name
- BD MAX CTGCTV2, BD MAX System
- Applicant
- Becton, Dickinson and Company
- Decision
- Substantially Equivalent
- Date received
- 2018-09-27
- Decision date
- 2019-01-08
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- OUY
- Device class
- 2
- Regulation number
- 866.3860
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Sparks, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
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