FDA.reportPublic FDA data

510(k) K896635

Device
Viral Respiratory Indirect Fluores. Mono. Antibody
Applicant
BAXTER HEALTHCARE CORP.
510(k) number
K896635
Product code
GNW
Decision
Substantially Equivalent (SESE)
Decision date
1990-02-02
Date received
1989-11-22
Regulation
866.3330
Classification name
Antisera, Cf, Influenza Virus A, B, C
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
HOWARD TAYLOR
Address
P.O. Box 3093 Bellevue WA US 98009 98009

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K061101D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITDiagnostic Hybrids, Inc.2006-11-20
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
K872693INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-09-18
K872694YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-09-18