Coagulation Factor Deficient Plasma

FDA 510(k) K840114 · Medical Specialties Laboratories

Substantially Equivalent

510(k) numberK840114

Submission

Device name
Coagulation Factor Deficient Plasma
Applicant
Medical Specialties Laboratories
Mchenry, IL, US
Received
January 11, 1984
Decision date
February 4, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GGP – Test, Qualitative And Quantitative Factor Deficiency
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7290
Specialty
Hematology

Other 510(k)s with product code GGP

510(k)DeviceApplicantDecision
K251440CRYOcheck Chromogenic Factor VIIIGGP · Traditional Precision Biologic, Inc.08/25/2025SE
K230852HemosIL Chromogenic Factor IXGGP · Traditional Instrumentation Laboratory Company12/13/2023SE
K220728vWF AgGGP · Traditional Siemens Healthcare Diagnostics Products GmbH06/02/2023SE
K214002CRYOcheck Chromogenic Factor IXGGP · Traditional Precision Biologic, Inc.12/23/2022SE
K223402HemosIL von Willebrand Factor AntigenGGP · Special Instrumentation Laboratory CO12/09/2022SE
K200033HemosIL von Willebrand Factor AntigenGGP · Special Instrumentation Laboratory CO08/19/2020SE
K193204Cryocheck Chromogenic Factor VIIIGGP · Traditional Precision Biologic07/17/2020SE
K183440CRYOcheck FVIII Inhibitor KitGGP · Traditional Precision Biologic, Inc.03/12/2019SE
K181525INNOVANCE Free PS AgGGP · Traditional Siemens Healthcare Diagnostics Products GmbH09/07/2018SE
K133005Hemosil Von Willebrand Activity AssayGGP · Special Instrumentation Laboratory CO03/13/2014SE

More from Instrumentation Laboratory CO

510(k)DeviceDecision
K852643Uni-Plate · Traditional 08/08/1985SE
K844897Hematology Control Uni-Cell 5, Uni-Cell 7 & 8JPK · Traditional 03/22/1985SE
K823587Uni-CellGLQ · Traditional 01/05/1983SE
K810268NormlceraKIS · Traditional 03/06/1981SE

Questions and answers

When was Coagulation Factor Deficient Plasma cleared by the FDA?

Coagulation Factor Deficient Plasma (K840114) received a 510(k) decision of Substantially Equivalent on February 4, 1984, 24 days after the submission was received.

What is the product code of K840114?

The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.