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510(k) K890051

Device
BIOTRACK APTT CONTROLS
Applicant
BIOTRACK, INC.
510(k) number
K890051
Product code
GIT  
Decision
Substantially Equivalent (SESE)
Decision date
1989-02-23
Date received
1989-01-06
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#

Contact
LAURA WINFREY
Address
1058 Huff Ave. Mountain View CA US 94043 94043

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
K881999PLATELIN(R) EXCEL LOrganon Teknika Corp.1988-08-17
K880711CLP 0.02 M CALCIUM CHLORIDE SOLUTION.Creative Laboratory Products, Inc.1988-03-18
K820450THROMBOSCREENPacific Hemostasis1982-03-26

Legacy Summary#

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FDA Review#

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