K093737 is an FDA 510(k) clearance for the HEMOSIL F11 & FV DNA CONTROL. This device is classified as a Quality Control Material, Genetics, Dna (Class II - Special Controls, product code NZB).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on May 4, 2010, 151 days after receiving the submission on December 4, 2009.
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 | K093737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2009 |
| Decision Date | May 04, 2010 |
| Days to Decision | 151 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. |