FDA 510(k) Applications Submitted by GAIL 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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