FDA.reportPublic FDA data

510(k) K781585

Device
HEMATOXYLIN STAIN HARRIS
Applicant
BIOSCIENTIFIC
510(k) number
K781585
Product code
HYK  
Decision
Substantially Equivalent (SESE)
Decision date
1978-10-10
Date received
1978-09-18
Regulation
864.1850
Classification name
Hematoxylin Harris's
Medical specialty
Hematology
Review panel
Pathology
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 HYK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K873107INSTANT HEMATOXYLINShandon, Inc.1987-08-21
K872498HARRIS HEMATOXYLINAnatech, Ltd.1987-07-09
K843425HARRIS HEMATOXYLIN, MERCURY FREE, ACIDAccra Laboratories, Inc.1984-10-02
K823328HARRIS HEMATOXYLINAccra Laboratories, Inc.1982-12-28
K810733HARRIS HEMATOXYLINSurgipath1981-04-14
K800324VOLU-SOL HARRIS HEMATOXYLINVolu Sol Medical Industries1980-02-22

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases