510(k) K933457

Device: RIM E.COLI 0157:H7 LATEX TEST
Applicant: REMEL CO.
510(k) number: K933457
Product code: GNA
Decision: Substantially Equivalent (SESE)
Decision date: 1994-04-20
Date received: 1993-07-14
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: Statement
Third party reviewed: No

Applicant Contact#

Contact: DAVID A WALL
Address: 12076 Santa Fe Dr. Lenexa KS US 66215 66215

FDA Registration Numbers#

9611882
1119779
8020667
1025402
8010096
3008987086
3038206980
1524213
8010383
3043127699
1924669
3003750284

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GNA #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K071799	MODIFICATION TO BIOSTAR OIA SHIGATOX	Iverness Medical Professional Diagnostics	2007-10-02
K031367	DUOPATH VEROTOXINS GLISA TEST	Emd Chemicals, Inc.	2004-01-23
K993401	DRYSPOT E.COLI 0157 KIT	Oxoid , Ltd.	2000-02-28
K981734	VTEC-RPLA SEIKEN	Denka Seiken'S	1998-09-22
K962028	WELLCOLEX E-COLI OI57 ZC60	Murex Diagnostics, Inc.	1996-11-01
K953362	PREMIER EHEC	Meridian Diagnostics, Inc.	1995-11-14
K950167	PREMIER EHEC	Meridian Diagnostics, Inc.	1995-04-14
K903714	E. COLI 0157 LATEX TEST	Pro-Lab, Inc.	1991-01-24
K884026	ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT	Oxoid U.S.A., Inc.	1989-02-03
K874288	PHADEBACT ETEC-LT TEST	Pharmacia, Inc.	1988-09-02
K855234	DIAGNOSTIC REAGENT VET-RPLA	Oxoid U.S.A., Inc.	1986-11-04

Legacy Summary#

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