510(k) Report

Devices descending from K964152

6 later devices reach Unicap Total Ige Assay/Pharmacia Total Ige Controls LMH through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133404Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMHPhadia AB201422
+1K050493Quantia IgeBiokit, S.A.20051—
+1K034057LacrytestAdiatec SA20040—
+2K214068Quantia IgEBiokit, S.A.20230—
+2K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE…Phadia AB201611
+3K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.20240—