FDA.reportPublic FDA data

510(k) K183440

Device
CRYOcheck FVIII Inhibitor Kit
Applicant
Precision BioLogic Inc.
510(k) number
K183440
Product code
GGP  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-12
Date received
2018-12-12
Regulation
864.7290
Classification name
Test, Qualitative And Quantitative Factor Deficiency
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Karen M. Black
Address
140 Eileen Stubbs Ave. Darmouth CA B3B 0A9 B3B 0A9

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GGP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.2025-08-25
K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory Company2023-12-13
K220728vWF AgSiemens Healthcare Diagnostics Products GmbH2023-06-02
K214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.2022-12-23
K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO2022-12-09
K200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO2020-08-19
K193204Cryocheck Chromogenic Factor VIIIPrecision Biologic2020-07-17
K181525INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbH2018-09-07
K133005HEMOSIL VON WILLEBRAND ACTIVITY ASSAYInstrumentation Laboratory CO2014-03-13
K102164HEMOSIL PROTEIN S ACTIVITY ASSAYInstrumentation Laboratory CO2011-03-17
K092170STA LIATEST FREE PSDiagnostica Stago, Inc.2009-12-22
K082631THROMBO TEK PSE, MODEL 90-480R2 Diagnostics, Inc.2008-12-17
K082205FACTOR VIII ANTIBODY SCREENGenetic Testing Institute2008-11-20
K063323SPECTROLYSE PAI-1, MODEL 101201American Diagnostica, Inc.2007-08-15
K070635HEMOSIL PROCLOTInstrumentation Laboratory CO2007-03-29

FDA Review#

Decision Summary