510(k) Report

Devices descending from K963048

2 later devices reach Immage System Rheumatoid Factor (RF) Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971602Array Systems Rheumatoid Factor (Rfmpe) ReagentBeckman Instruments, Inc.19970—
+1K971788Synchron Systems Rheumatoid Factor (RF) Reagent, Synchron CX Systems RF CalibratorBeckman Instruments, Inc.199702