FDA.reportPublic FDA data

510(k) K843367

Device
Rotavirus Enzyme Immunoassay
Applicant
INTL. DIAGNOSTIC LABORATORIES, LTD.
510(k) number
K843367
Product code
LIQ
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-13
Date received
1984-08-28
Regulation
866.3405
Classification name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
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