510(k) Report

Devices descending from K032194

2 later devices reach Tigris DTS Automated Analyzer for Automating Amplified Nucleic Acid Test Assays through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111409Aptima Combo 2 AssayGen-Probe, Inc.20121—
+2K132251Aptima Combo 2 Assay (Panther System)Hologic / Gen-Probe Incorporated201302