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510(k) K061101

Device
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
Applicant
DIAGNOSTIC HYBRIDS, INC.
510(k) number
K061101
Product code
GNW  
Decision
Substantially Equivalent (SESE)
Decision date
2006-11-20
Date received
2006-04-20
Regulation
866.3330
Classification name
Antisera, Cf, Influenza Virus A, B, C
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GAIL R GOODRUM
Address
350 W. State St. Athens OH US 45701 45701

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GNW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K092882D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KITDiagnostic Hybrids, Inc.2009-10-21
K092300MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITDiagnostic Hybrids, Inc.2009-08-28
K081746D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KITDiagnostic Hybrids, Inc.2008-12-23
K022713DFA RESPIRATORY VIRUS SCREENING & ID KITDiagnostic Hybrids, Inc.2002-12-18
K003204BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KITIntracel Corp.2000-11-07
K974302LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU BLight Diagnostics1998-04-08
K973954IMAGEN RESPIRATORY SCREENDako Diagnostics , Ltd.1997-12-22
K962037IMAGEN RESPIRATORY SCREENDako Diagnostics , Ltd.1996-12-26
K942172INFLUENZA A ANTIGEN TESTNeogenex1994-07-06
K942174INFLUENZA B ANITGEN TESTNeogenex1994-06-30
K913351INFLUENZA MAB TEST/INFLUENZA A TESTGull Laboratories, Inc.1991-12-17
K913214INFLUENZA MAB TEST/INFLUENZA B TESTGull Laboratories, Inc.1991-12-13
K896635VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODYBaxter Healthcare Corp1990-02-02
K872693INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-09-18
K872694YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-09-18

Legacy Summary#

summary

FDA Review#

Decision Summary