FDA.reportPublic FDA data

510(k) K251440

Device
CRYOcheck Chromogenic Factor VIII
Applicant
Precision Biologic, Inc.
510(k) number
K251440
Product code
GGP
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-25
Date received
2025-05-09
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 Black
Address
140 Eileen Stubbs Ave. Dartmouth CA B3B0A9 B3B0A9

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
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
K183440CRYOcheck FVIII Inhibitor KitPrecision Biologic, Inc.2019-03-12
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