FDA 510(k) Applications Submitted by GAIL R GOODRUM

FDA 510(k) Number Submission Date Device Name Applicant
K070206 01/22/2007 DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 DIAGNOSTIC HYBRIDS, INC.
K070265 01/29/2007 DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 DIAGNOSTIC HYBRIDS, INC.
K063675 12/11/2006 DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT DIAGNOSTIC HYBRIDS, INC.
K063798 12/22/2006 DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 DIAGNOSTIC HYBRIDS, INC.
K090073 01/12/2009 D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC.
K061101 04/20/2006 D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT DIAGNOSTIC HYBRIDS, INC.
K081164 04/24/2008 D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC.
K081746 06/19/2008 D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT DIAGNOSTIC HYBRIDS, INC.
K081928 07/07/2008 D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT DIAGNOSTIC HYBRIDS, INC.
K083391 11/17/2008 THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY DIAGNOSTIC HYBRIDS, INC.


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