510(k) Report

Devices descending from K972526

3 later devices reach Methadone Eia Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023317Methadone Enzyme ImmunoassayLin-Zhi International, Inc.20022—
+2K192433LZI Methadone II Enzyme ImmunoassayLin-Zhi International, Inc.20190—
+2K033885BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc.20040—