510(k) K063224
- Device
- GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
- Applicant
- GENTRIS CORPORATION
- 510(k) number
- K063224
- Product code
- NZB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-12-22
- Date received
- 2006-10-24
- Regulation
- 866.5910
- Classification name
- Quality Control Material, Genetics, Dna
- Medical specialty
- Microbiology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBORAH N KLOOS
- Address
- 133 Southcenter Ct. Suite 400 Morrisville NC US 27560 27560
FDA Registration Numbers#
- 3014150341
- 3014673819
- 3022778613
- 2431530
- 3005959679
- 3017467459
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NZB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093737 | HEMOSIL F11 & FV DNA CONTROL | Instrumentation Laboratory CO | 2010-05-04 |
| K083171 | INTROL CF PANEL I CONTROL, MODEL: G106 | Maine Molecular Quality Controls, Inc. | 2008-12-16 |
| DEN060007 | INTROL CF PANEL I CONTROL | Maine Molecular Quality Controls, Inc. | 2006-10-12 |
Legacy Summary#
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FDA Review#
Decision Summary