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510(k) K924893

Device
MICROSPORIDIUM CONTROL SLIDE
Applicant
SCIENTIFIC DEVICE LABORATORY, INC.
510(k) number
K924893
Product code
LJG  
Decision
Substantially Equivalent (SESE)
Decision date
1993-01-15
Date received
1992-09-28
Regulation
866.2660
Classification name
Quality Control Slides
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
STEWART LIPTON
Address
508 Zenith Dr. Glenview IL US 60025 60025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LJG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K943228MICROSPORIDIUM CONTROL SETMeridian Diagnostics, Inc.1994-10-27
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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