510(k) Report

Devices descending from K971809

4 later devices reach Isolate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991341Isolate, Isolate Concentrate, Isolate Stock SolutionIrvine Scientific Sales Co., Inc.199911
+1K980814PurespermNidacon International AB19981—
+2K023403Spermgrad, Models 10022/10063Vitrolife Sweden AB20020—
+2K984172Modification of PurespermNidacon International AB19990—