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510(k) K862725

Device
SACCOMANNO SPECIMAN SOLUTION
Applicant
MILL-ROSE LABORATORY
510(k) number
K862725
Product code
LDZ  
Decision
Substantially Equivalent (SESE)
Decision date
1986-08-01
Date received
1986-07-17
Regulation
864.4010
Classification name
Fixative, Alcohol Containing
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MARK KOZAK
Address
7310 Corporate Blvd. Mentor OH US 44060 44060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LDZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K883048ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTIONAlpha-Tec Systems, Inc.1988-08-17
K881922CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVESurgipath Medical Industries, Inc.1988-05-25
K881698ATS PVA FIXATIVE SOLUTIONAlpha-Tec Systems, Inc.1988-05-13
K843428BIOFIXAccra Laboratories, Inc.1984-09-27
K842913WRIGHT STAIN FIXATIVEE K Ind., Inc.1984-09-07
K831061PVA FIXATIVE/FORMALINAmerican Micro Scan1983-06-08
K761138FA TISSUE FIXATIVE & WASH SETZeus Scientific, Inc.1978-01-06

Legacy Summary#

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FDA Review#

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