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510(k) K943228

Device
MICROSPORIDIUM CONTROL SET
Applicant
MERIDIAN DIAGNOSTICS, INC.
510(k) number
K943228
Product code
LJG  
Decision
Substantially Equivalent (SESE)
Decision date
1994-10-27
Date received
1994-07-06
Regulation
866.2660
Classification name
Quality Control Slides
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ALLEN D NICKOL
Address
3471 River Hills Dr. Cincinnati OH US 45244 45244

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LJG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K924893MICROSPORIDIUM CONTROL SLIDEScientific Device Laboratory, Inc.1993-01-15
K890718GRAM STAIN CONTROL SLIDEScientific Device Laboratory, Inc.1989-03-16
K890670CRYPTOSPORIDIUM CONTROL SLIDEScientific Device Laboratory, Inc.1989-03-16
K890616BION DIRECT IDENTIFICATION CONTROL SLIDEBion Ent., Ltd.1989-02-17
K883571HISTO-CHECK PARASITIC CONTROL SLIDESVal Tech Diagnostics, Inc.1988-10-06
K883570HISTO-CHECK FUNGAL CONTROL SLIDESVal Tech Diagnostics, Inc.1988-10-06
K883569HISTO-CHECK GRAM NEGATIVE SLIDESVal Tech Diagnostics, Inc.1988-10-06
K883568HISTO-CHECK ACID FAST SLIDESVal Tech Diagnostics, Inc.1988-10-06
K883567HISTO-CHECK LEGIONELLA CONTROL SLIDESVal Tech Diagnostics, Inc.1988-10-06
K883208HISTO-CHECK SLIDESVal Tech Diagnostics, Inc.1988-08-25
K881106ACID FAST BACILLI HISTOLOGY CONTROL SLIDESSigma Diagnostics, Inc.1988-04-21
K881109SPIROCHETES HISTOLOGY CONTROL SLIDESSigma Diagnostics, Inc.1988-04-21
K881112FUNGI HISTOLOGY CONTROL SLIDESSigma Diagnostics, Inc.1988-04-21
K881110LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDESSigma Diagnostics, Inc.1988-04-12
K881108PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDESSigma Diagnostics, Inc.1988-04-12

Legacy Summary#

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FDA Review#

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