510(k) Report

Devices descending from K003098

4 later devices reach Access Ultrasensitive HGH Calibrators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061282Access Ultrasensitive HGH Calibrator, Model 33585Beckman Coulter, Inc.20060—
+1K042651Free T3 Calibrators on the Access Immunoassay SystemsBeckman Coulter, Inc.200401
+1K040181Access Dhea-S Reagent AssayBeckman Coulter, Inc.20041—
+2K111762ST Aia-Pack Dhea-S Calibrator SetTosoh Bioscience, Inc.20110—