510(k) Report

Devices descending from K983399

6 later devices reach Giardia/Cryptosporidium Combo Rapid Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031942Xpect Giardia Lateral Flow Assay, Model 2450020Remel, Inc.20032—
+1K031965Xpect Cryptosporidium Lateral Flow Assay, Model 2451020Remel, Inc.200311
+1K031834Xpect Giardia/Cryptosporidium Lateral Flow AssayRemel, Inc.200301
+2K120001Unigold GiardiaTrinity Biotech20130—
+2K121565Uni-Gold CryptosporidiumTrinity Biotech20130—
+2K081064Giardia Fecal Antigen Detection Lateral Flow Kit, Model GL-LFIvd Research, Inc.20090—