BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
FDA 510(k) clearance K213280 · decided 2023-05-04
Clearance details
- K-number
- K213280
- Device name
- BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
- Applicant
- Bd Kiestra B.V.
- Decision
- Substantially Equivalent
- Date received
- 2021-10-01
- Decision date
- 2023-05-04
- Days to decision
- 580 days
- Clearance type
- Traditional
- Product code
- QQY
- Device class
- 2
- Regulation number
- 866.2190
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Drachten, NL
- 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 |
|---|---|---|
| APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module (K200839) | Clever Culture Systems | 2021-10-28 |
Recalls involving this device
No recalls on record reference this clearance.