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510(k) K812193

Device
KOH MOUNTING FLUID
Applicant
AMERICAN SCIENTIFIC PRODUCTS
510(k) number
K812193
Product code
LEB  
Decision
Substantially Equivalent (SESE)
Decision date
1981-08-31
Date received
1981-08-03
Regulation
864.4010
Classification name
Mounting Media
Medical specialty
Pathology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LEB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842986REFRAX MOUNTING MEDIUMAnatech, Ltd.1984-08-21
K821019PHOSPHATE BUFFERED CLYCEROL MOUNTING FLUMicrobiological Research Corp.1982-04-26
K811799CLEAR-MOUNTRichard-Allan Medical Ind., Inc.1981-07-31
K760838LACTO-PHENOL COTTON BLUE MOUNTING FL.I M, Inc.1976-11-16

Legacy Summary#

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FDA Review#

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