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510(k) K881110

Device
Legionella Pneumophilla Histology Control Slides
Applicant
SIGMA DIAGNOSTICS, INC.
510(k) number
K881110
Product code
LJG
Decision
Substantially Equivalent (SESE)
Decision date
1988-04-12
Date received
1988-03-15
Regulation
866.2660
Classification name
Quality Control Slides
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TAKES, PHD
Address
P.O. Box 14508 St. Louis MO US 63178 63178

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
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
K881108PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDESSigma Diagnostics, Inc.1988-04-12