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510(k) K831058

Device
SAF FIXATIVE
Applicant
AMERICAN MICRO SCAN
510(k) number
K831058
Product code
LDW  
Decision
Substantially Equivalent (SESE)
Decision date
1983-06-08
Date received
1983-04-01
Regulation
864.4010
Classification name
Fixative, Acid Containing
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 LDW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K883062ATS SCHAUDINN'S FIXATIVE W/ACETIC ACIDAlpha-Tec Systems, Inc.1988-08-04
K842923PICRIC ACID 1% W/VE K Ind., Inc.1984-09-11
K842922PICRIC ACID SATURATED SOLUTIONE K Ind., Inc.1984-09-07

Legacy Summary#

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FDA Review#

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