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510(k) K813512

Device
RHESUS MONKEY BLOOD IN ALSEVER'S
Applicant
DUTCHLAND LABORATORIES, INC.
510(k) number
K813512
Product code
LHW  
Decision
Substantially Equivalent (SESE)
Decision date
1981-12-29
Date received
1981-12-15
Regulation
866.3720
Classification name
Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
Medical specialty
Microbiology
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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LHW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K820848BLUE RIDGE SHEEP BLOODBlue Ridge Media Co.1982-04-16
K820849BLUE RIDGE RABBIT BLOODBlue Ridge Media Co.1982-04-16
K813513AFRICAN GREEN MONKEY BLOOD IN ALSERVERSDutchland Laboratories, Inc.1981-12-31

Legacy Summary#

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FDA Review#

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