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510(k) K821320

Device
Hematoxylin Stain
Applicant
SIGMA CHEMICAL CO.
510(k) number
K821320
Product code
HYJ
Decision
Substantially Equivalent (SESE)
Decision date
1982-06-02
Date received
1982-05-04
Regulation
864.1850
Classification name
Hematoxylin
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 HYJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K872499ANATECH HEMATOXYLIN-NORMAL STRENGTHAnatech, Ltd.1987-07-09
K872500ANATECH HEMATOXYLIN-EXTRA STRENGTHAnatech, Ltd.1987-07-09
K842740DELAFIELD HEMATOXYLIN STAINE K Ind., Inc.1984-08-17
K842741GILL HEMATOXYLIN STAINE K Ind., Inc.1984-08-15
K831090HEMATOXYLIN GILL FORMULATION IX#56016Accra Laboratories, Inc.1983-06-08
K822352HEMATOXYLIN STAIN SOLUTIONFisher Scientific Co., LLC1982-08-16
K821533HEMATOXYLIN IVolu Sol Medical Industries1982-06-10
K821540HEMATOXYLIN IIVolu Sol Medical Industries1982-06-10
K821541HEMATOXYLIN IIIVolu Sol Medical Industries1982-06-10
K821062HEMATOXYLIN SOLUTIONSigma Chemical Co.1982-04-29
K811802HEMATOXYLINRichard-Allan Medical Ind., Inc.1981-07-28
K810758GILL'S HEMATOXYLIN #1Surgipath1981-04-14
K810759GILL'S HEMATOXYLIN #2Surgipath1981-04-14