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510(k) K893663

Device
INSTANT EOSIN-AQUEOUS
Applicant
SHANDON, INC.
510(k) number
K893663
Product code
HYB  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-13
Date received
1989-05-15
Regulation
864.1850
Classification name
Eosin Y
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JANET CROOKHAM
Address
171 Industry Dr. Pittsburgh PA US 15275 15275

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HYB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K880596EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINESigma Chemical Co.1988-03-31
K880240INSTANT EOSIN-ALCOHOLICShandon, Inc.1988-03-03
K843426EOSIN Y 1% ALCOHOLICAccra Laboratories, Inc.1984-09-27
K822982MIDAS 100 HEMACOLOR STAIN #66030Emd Chemicals, Inc.1982-10-27
K821574EOSIN Y SOLUTIN, AGUEOUSSigma Chemical Co.1982-06-10
K821573EOSIN Y SOLUTION ALCHOLICSigma Chemical Co.1982-06-09
K811797EOSIN-YRichard-Allan Medical Ind., Inc.1981-07-28
K811826EOSIN YSurgipath1981-07-10
K800942VOLU-SOL EOSIN Y STAINVolu Sol Medical Industries1980-05-08

Legacy Summary#

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FDA Review#

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