510(k) K842986

Device
REFRAX MOUNTING MEDIUM
Applicant
ANATECH, LTD.
510(k) number
K842986
Product code
LEB  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-21
Date received
1984-07-30
Regulation
864.4010
Classification name
Mounting Media
Medical specialty
Pathology
Review panel
Pathology
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
K821019PHOSPHATE BUFFERED CLYCEROL MOUNTING FLUMicrobiological Research Corp.1982-04-26
K812193KOH MOUNTING FLUIDAmerican Scientific Products1981-08-31
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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