DEN060007 is an FDA 510(k) submission for the INTROL CF PANEL I CONTROL. This device is classified as a Quality Control Material, Genetics, Dna (Class II - Special Controls, product code NZB).
Submitted by Maine Molecular Quality Controls, Inc. (Scarborough, US). The FDA issued a Not Cleared (DENG) decision on October 12, 2006.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 866.5910. Dna Quality Control Material For Genetic Testing Is A Device Intended For Medical Purposes For Use In A Test System To Estimate Test Precision And To Detect Systematic Analytical Deviations That May Arise From Reagent Or Analytical Instrument Variation. This Type Of Device Includes Synthetic Dna Controls And Cell-line Based Controls..
| 510(k) Number | DEN060007 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 14, 2006 |
| Decision Date | October 12, 2006 |
| Days to Decision | 59 days |
| Submission Type | Post-NSE |
| Review Panel | Pathology (PA) |
| Summary | - |
| Product Code | NZB - Quality Control Material, Genetics, Dna |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5910 |
| Definition | Dna Quality Control Material For Genetic Testing Is A Device Intended For Medical Purposes For Use In A Test System To Estimate Test Precision And To Detect Systematic Analytical Deviations That May Arise From Reagent Or Analytical Instrument Variation. This Type Of Device Includes Synthetic Dna Controls And Cell-line Based Controls. |