FDA 510(k) Applications for Medical Device Product Code "GQL"
(Antisera, Fluorescent, Herpesvirus Hominis 1,2)

FDA 510(k) Number Applicant Device Name Decision Date
K091753 DIAGNOSTIC HYBRIDS, INC. ELVIS HSV ID AND D3 TYPING TEST SYSTEM 08/28/2009
K081527 MILLIPORE CORPORATION LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT 04/01/2009
K984135 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR 05/26/1999
K984120 ZEUS SCIENTIFIC, INC. THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH 05/26/1999


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