Federal Register: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical Use

The FDA is classifying the high throughput genomic sequence analyzer for clinical use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the cl...
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Equipment Source Type: news