510(k) K213280
- Device
- BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
- Applicant
- Bd Kiestra B.V.
- 510(k) number
- K213280
- Product code
- QQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-04
- Date received
- 2021-10-01
- Regulation
- 866.2190
- Classification name
- Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Karin Brands
- Address
- Marconilaan 6 Drachten NL 9207 JC 9207 JC
FDA Registration Numbers#
- 3009288740
- 3023339158
- 3010141591
- 1119779
Source Documents#
Other 510(k) Records For Product Code QQY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200839 | APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module | Clever Culture Systems | 2021-10-28 |