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510(k) K915137

Device
KALLESTAD ROTAVIRUS MICROPLATE
Applicant
BIO-RAD LABORATORIES, INC.
510(k) number
K915137
Product code
LIQ  
Decision
Substantially Equivalent (SESE)
Decision date
1992-03-04
Date received
1991-11-13
Regulation
866.3405
Classification name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHERI W.FINK
Address
1000 Lake Hazeltine Dr. Chaska MN US 55318 55318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LIQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K990842SAS ROTA TESTSa Scientific, Inc.1999-08-09
K972895VIDAS ROTAVIRUS (RTV) ASSAYBiomerieux Vitek, Inc.1997-10-03
K971585IMMUNOCARD STAT! ROTAVIRUSMeridian Diagnostics, Inc.1997-08-20
K964424ROTAVIRUS EIATrinity Biotech, Inc.1997-08-08
K965092VIDAS ROTAVIRUS ASSAYBiomerieux Vitek, Inc.1997-05-05
K951208ROTA-DAN RAPID ROTAVIRUS EIA KITEldan Technologies, Ltd.1996-02-14
K942286DIARLEX ROTA-ADENOOrion Diagnostica, Inc.1994-12-14
K933587IMMUNOCARD ROTAVIRUSMeridian Diagnostics, Inc.1994-02-03
K932384IDEIA(TM) ROTAVIRUSDako Diagnostics , Ltd.1993-12-27
K912666DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440Dako Corp.1992-02-14
K895805SLIDEX ROTA-KIT 2Vitek Systems, Inc.1991-02-26
K884017ROTACUBEDifco Laboratories, Inc.1989-01-24
K883940ORTHO* ROTAVIRUS LATEX AGGLUTINATION TESTOrtho Diagnostic Systems, Inc.1989-01-04
K883935ORTHO* ROTAVIRUS ANTIGEN ELISA TESTOrtho Diagnostic Systems, Inc.1989-01-04
K880821RESUBMITTED ABBOTT TESTPACK ROTAVIRUSAbbott Laboratories1988-05-06

Legacy Summary#

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FDA Review#

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