FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
PAXgene Blood DNA Tube
K Number: K142821
·
Decision Sep 9, 2015
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
7
Applicant Total
4
Review Days
344
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Basic Information
- Device Name
- PAXgene Blood DNA Tube
- K Number
- K142821
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Preanalytix GmbH
- Date Received
- September 30, 2014
- Decision Date
- September 9, 2015
- Product Code
- PJE
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| PJE | Blood/Plasma Collection Device For Dna Testing | FDA class 2 | Clinical Chemistry |
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