iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
FDA 510(k) clearance K221802 · decided 2023-04-03
Clearance details
- K-number
- K221802
- Device name
- iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
- Applicant
- Mawi Dna Technologies
- Decision
- Substantially Equivalent
- Date received
- 2022-06-21
- Decision date
- 2023-04-03
- Days to decision
- 286 days
- Clearance type
- Traditional
- Product code
- QBD
- Device class
- 2
- Regulation number
- 866.2950
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Hayward, CA, US
- Third-party review
- No
- Expedited review
- No
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| DNA/RNA Shield SafeCollect Saliva Collection kit (K231013) | Zymo Research | 2023-09-28 |
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| Spectrum Saliva Collection Device (K223497) | Spectrum Solutions, LLC | 2023-02-17 |
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Recalls involving this device
No recalls on record reference this clearance.