FDA.reportPublic FDA data

510(k) K924006

Device
Bartel Prima System Influenza A Enzyme Immunoassay
Applicant
BAXTER HEALTHCARE CORP.
510(k) number
K924006
Product code
GNX
Decision
Substantially Equivalent (SESE)
Decision date
1992-12-29
Date received
1992-08-10
Regulation
866.3330
Classification name
Antigens, Cf (Including Cf Control), 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
NANCY MALLINAK
Address
2005 NW Sammamish Rd. Suite 107 Issauah WA US 98027 98027

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K131804REMEL XPECT FLU A&BRemel, Inc.2013-07-12
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K971494VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSESZymetx, Inc.1997-09-10
K901493FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE BWhittaker Bioproducts, Inc.1990-06-27
K893579FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE AWhittaker Bioproducts, Inc.1990-01-16
K884191INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTIONBaxter Diagnostics, Inc.1988-11-22
K872958IMAGEN INFLUENZA VIRUS A AND B TESTMIBoots-Celltech Diagnostics, Inc.1988-02-24
K871231ANTIBODY ASSAY FOR DETECTION OF INFLUENZA BMicroscan Div. Baxter Healthcare Corp.1987-06-26
K871233ANTIBODY ASSAY FOR DETECTION OF INFLUENZA AMicroscan Div. Baxter Healthcare Corp.1987-06-26
K843659INFLUENZA A2 VIRUSInstitute Virion , Ltd.1985-09-26