510(k) Report

Devices descending from K900695

3 later devices reach Enzymun Test (R) Prolactin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964748Elecsys Prolactin AssayBoehringer Mannheim Corp.19972—
+2K052982Roche Diagnostics Cobas Elecsys Prolactin II CalsetRoche Diagnostics20051—
+3K163544Lumipulse G ProlactinFujirebio Diagnostics,Inc.20170—