FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DNA/RNA Shield Collection Tube
K Number: K202641
·
Decision Dec 14, 2020
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
16
Applicant Total
2
Review Days
94
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Basic Information
- Device Name
- DNA/RNA Shield Collection Tube
- K Number
- K202641
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.2950
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zymo Research
- Date Received
- September 11, 2020
- Decision Date
- December 14, 2020
- 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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Other Clearances by Zymo Research
| K Number | Device Name | ||
|---|---|---|---|
| K231013 | DNA/RNA Shield SafeCollect Saliva Collection kit | Sep 28, 2023 | Substantially Equivalent |