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510(k) K820533

Device
B4182-1
Applicant
AMERICAN SCIENTIFIC PRODUCTS
510(k) number
K820533
Product code
GIE  
Decision
Substantially Equivalent (SESE)
Decision date
1982-04-08
Date received
1982-03-02
Regulation
864.5400
Classification name
Fibrometer
Medical specialty
Hematology
Review panel
Hematology
Device class
2
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 GIE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K820532DISPO FIBRIN PIPET TIPS B4182-2American Scientific Products1982-04-08

Legacy Summary#

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FDA Review#

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