FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MagXtract Collection Tube
K Number: K212113
·
Decision Jul 28, 2022
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
16
Applicant Total
1
Review Days
386
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Basic Information
- Device Name
- MagXtract Collection Tube
- K Number
- K212113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.2950
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Magbio Genomics, Inc.
- Date Received
- July 7, 2021
- Decision Date
- July 28, 2022
- Product Code
- QBD
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QBD | Microbial Nucleic Acid Storage And Stabilization Device | FDA class 2 | Microbiology |
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