K083171 is an FDA 510(k) clearance for the INTROL CF PANEL I CONTROL, MODEL: G106. 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 Cleared decision on December 16, 2008, 50 days after receiving the submission on October 27, 2008.
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 | K083171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2008 |
| Decision Date | December 16, 2008 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| 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. |