Today, the @US_FDA proposes to reclassify two types of hepatitis C virus (HCV) diagnostic tests from class III to II. If this reclassification is finalized, tests of this type and use may go through the FDA ’ s 510(k) pathway for clearance.

Today, the @US_FDA proposes to reclassify two types of hepatitis C virus (HCV) diagnostic tests from class III to II. If this reclassification is finalized, tests of this type and use may go through the FDA’s 510(k) pathway for clearance.
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Devices Authors: Source Type: news