510(k) Report

Devices descending from P850048

3 later devices reach Tandem-R Psa Immunoradiometric Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984289Vitros Immunodiagnostic Products Psa Calibrators, Vitros Immunodiagnostic Products Psa…Ortho-Clinical Diagnostics, Inc.19990—
+1K974816Access (R) Psa Reagents on the Access (R) Immunoassay Analyzer 33220, 33225, 33229Beckman Instruments, Inc.19980—
+1K965085Enzymun-Test PsaBoehringer Mannheim Corp.19970—