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510(k) K881999

Device
PLATELIN(R) EXCEL L
Applicant
ORGANON TEKNIKA CORP.
510(k) number
K881999
Product code
GIT  
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-17
Date received
1988-05-12
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
TONI M STIFANO
Address
800 Capitola Dr. Durham NC US 27713 27713

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
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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