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510(k) K894045

Device
MODIFIED POLYCHROME IV STAIN
Applicant
DEVETEC, INC.
510(k) number
K894045
Product code
KFD  
Decision
Substantially Equivalent (SESE)
Decision date
1989-07-25
Date received
1989-06-07
Regulation
864.1850
Classification name
Aniline Blue
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PRICE, PHD
Address
P.O. Box 10275 Bradenton FL US 34282 34282

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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