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510(k) K981734

Device
VTEC-RPLA SEIKEN
Applicant
DENKA SEIKEN'S
510(k) number
K981734
Product code
GNA  
Decision
Substantially Equivalent (SESE)
Decision date
1998-09-22
Date received
1998-05-18
Regulation
866.3255
Classification name
Antisera, All Types, Escherichia Coli
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KEVIN MANGAN
Address
3-4-2 Nihonbashi Kayabacho, Chuo-Ku Tokyo JP 103-0025 103-0025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GNA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K071799MODIFICATION TO BIOSTAR OIA SHIGATOXIverness Medical Professional Diagnostics2007-10-02
K031367DUOPATH VEROTOXINS GLISA TESTEmd Chemicals, Inc.2004-01-23
K993401DRYSPOT E.COLI 0157 KITOxoid , Ltd.2000-02-28
K962028WELLCOLEX E-COLI OI57 ZC60Murex Diagnostics, Inc.1996-11-01
K953362PREMIER EHECMeridian Diagnostics, Inc.1995-11-14
K950167PREMIER EHECMeridian Diagnostics, Inc.1995-04-14
K933457RIM E.COLI 0157:H7 LATEX TESTRemel Co.1994-04-20
K903714E. COLI 0157 LATEX TESTPro-Lab, Inc.1991-01-24
K884026ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KITOxoid U.S.A., Inc.1989-02-03
K874288PHADEBACT ETEC-LT TESTPharmacia, Inc.1988-09-02
K855234DIAGNOSTIC REAGENT VET-RPLAOxoid U.S.A., Inc.1986-11-04

Legacy Summary#

summary

FDA Review#

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