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510(k) K872537

Device
PROTHROMBIN TIME TEST
Applicant
SCLAVO, INC.
510(k) number
K872537
Product code
GJS  
Decision
Substantially Equivalent (SESE)
Decision date
1987-08-27
Date received
1987-06-25
Regulation
864.7750
Classification name
Test, Time, Prothrombin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DEBRA HOFMEISTER
Address
5 Mansard Ct. Wayne NJ US 07470 07470

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GJS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253188CoaguChek XS Plus SystemRoche Diagnostics2025-10-24
K251564microINR SystemIline Microsystems, S.L.2025-07-21
K243543microINR SystemIline Microsystems, S.L.2025-02-27
K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.2024-03-15
K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott Laboratories2023-07-14
K231711microINR SystemIline Microsystems, S.L.2023-07-11
K211485STA- NeoPTimalDiagnostica Stago S.A.S2022-12-23
K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingCoagusense, Inc.2022-10-05
K213426HemosIL ReadiPlasTinInstrumentation Laboratory CO2022-08-16
K201185microINR SystemIline Microsystems, S.L.2020-12-18
K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc.2019-02-21
K180780microINR SystemIline Microsystems, S.L.2019-01-25
K180693CoaguChek XS Pro SystemRoche Diagnostics2018-04-19
K180684CoaguChek XS Plus SystemRoche Diagnostics2018-04-19
K170960CoaguChek Vantus SystemRoche Diagnostics2017-12-25

Legacy Summary#

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FDA Review#

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