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510(k) K951208

Device
Rota-dan Rapid Rotavirus Eia Kit
Applicant
ELDAN TECHNOLOGIES, LTD.
510(k) number
K951208
Product code
LIQ
Decision
Substantially Equivalent (SESE)
Decision date
1996-02-14
Date received
1995-03-17
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
GERALD M SLUTZKY
Address
P.O. Box 1270 Jerusalem IL 91012 91012

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
K942286DIARLEX ROTA-ADENOOrion Diagnostica, Inc.1994-12-14
K933587IMMUNOCARD ROTAVIRUSMeridian Diagnostics, Inc.1994-02-03
K932384IDEIA(TM) ROTAVIRUSDako Diagnostics , Ltd.1993-12-27
K915137KALLESTAD ROTAVIRUS MICROPLATEBio-Rad Laboratories, Inc.1992-03-04
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