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510(k) K871477

Device
NEUTRAL RED
Applicant
SIGMA CHEMICAL CO.
510(k) number
K871477
Product code
KFE  
Decision
Substantially Equivalent (SESE)
Decision date
1987-04-29
Date received
1987-04-14
Regulation
864.1850
Classification name
Neutral Red
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM STARKWEATHER
Address
P.O. Box 14508 St. Louis MO US 63178 63178

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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