FDA.reportPublic FDA data

510(k) K873107

Device
INSTANT HEMATOXYLIN
Applicant
SHANDON, INC.
510(k) number
K873107
Product code
HYK  
Decision
Substantially Equivalent (SESE)
Decision date
1987-08-21
Date received
1987-08-07
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#

Contact
JANET N CROOKHAM,BA
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 HYK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K781585HEMATOXYLIN STAIN HARRISBioscientific1978-10-10

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