K131508 is an FDA 510(k) clearance for the VYSIS D7S486/CEP 7 FISH PROBE KIT. This device is classified as a Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders (Class II - Special Controls, product code PFG).
Submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on September 13, 2013, 112 days after receiving the submission on May 24, 2013.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1870. Dna Fish Probe Kits For Specimen Characterization Detect Dna Probe Targets On Human Chromosomes In Bone Marrow And Peripheral Blood Specimens..
| 510(k) Number | K131508 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2013 |
| Decision Date | September 13, 2013 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | PFG - Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.1870 |
| Definition | Dna Fish Probe Kits For Specimen Characterization Detect Dna Probe Targets On Human Chromosomes In Bone Marrow And Peripheral Blood Specimens. |