FDA.reportPublic FDA data

510(k) K820450

Device
THROMBOSCREEN
Applicant
PACIFIC HEMOSTASIS
510(k) number
K820450
Product code
GIT  
Decision
Substantially Equivalent (SESE)
Decision date
1982-03-26
Date received
1982-02-18
Regulation
864.7925
Classification name
Reagent & Control, Partial Thromboplastin Time
Medical specialty
Hematology
Review panel
Hematology
Device class
2
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 GIT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K890051BIOTRACK APTT CONTROLSBiotrack, Inc.1989-02-23
K881999PLATELIN(R) EXCEL LOrganon Teknika Corp.1988-08-17
K880711CLP 0.02 M CALCIUM CHLORIDE SOLUTION.Creative Laboratory Products, Inc.1988-03-18

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