510(k) Report

Devices descending from K932458

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012120Validate Chem 4 Calibration Verification Test Set, Model 10004Maine Standards Co.20013—
+2K091225Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test SetMaine Standards Co.20091—
+2K041975Validate Lipoprotein Calibration Verification Test Set, Model 501Maine Standards Co.20040—
+3K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…Radiometer America, Inc.20160—