MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
FDA 510(k) clearance K082150 · decided 2009-02-04
Clearance details
- K-number
- K082150
- Device name
- MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
- Applicant
- Preanalytix GmbH
- Decision
- Substantially Equivalent
- Date received
- 2008-07-30
- Decision date
- 2009-02-04
- Days to decision
- 189 days
- Clearance type
- Special
- Product code
- NTW
- Device class
- 2
- Regulation number
- 866.4070
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Franklin Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PAXGENE BLOOD RNA SYSTEM (DEN050003) | Preanalytix GmbH | 2005-04-18 |
Recalls involving this device
No recalls on record reference this clearance.