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510(k) K821573

Device
Eosin Y Solution Alcholic
Applicant
SIGMA CHEMICAL CO.
510(k) number
K821573
Product code
HYB
Decision
Substantially Equivalent (SESE)
Decision date
1982-06-09
Date received
1982-05-27
Regulation
864.1850
Classification name
Eosin Y
Medical specialty
Hematology
Review panel
Hematology
Device class
1
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 HYB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K893663INSTANT EOSIN-AQUEOUSShandon, Inc.1989-06-13
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
K811797EOSIN-YRichard-Allan Medical Ind., Inc.1981-07-28
K811826EOSIN YSurgipath1981-07-10
K800942VOLU-SOL EOSIN Y STAINVolu Sol Medical Industries1980-05-08