Thromboplastin

FDA 510(k) K810350 · Pacific Hemostasis

Substantially Equivalent

510(k) numberK810350

Submission

Device name
Thromboplastin
Applicant
Pacific Hemostasis
Walker, MI, US
Received
February 10, 1981
Decision date
April 14, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GJS – Test, Time, Prothrombin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7750
Specialty
Hematology

Other 510(k)s with product code GJS

510(k)DeviceApplicantDecision
K253188CoaguChek XS Plus SystemGJS · Special Roche Diagnostics10/24/2025SE
K251564microINR SystemGJS · Traditional Iline Microsystems, S.L.07/21/2025SE
K243543microINR SystemGJS · Traditional Iline Microsystems, S.L.02/27/2025SE
K230802Xprecia Prime Coagulation SystemGJS · Dual Track Universal Biosensors Pty, Ltd.03/15/2024SE
K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional Abbott Laboratories07/14/2023SE
K231711microINR SystemGJS · Special Iline Microsystems, S.L.07/11/2023SE
K211485STA- NeoPTimalGJS · Traditional Diagnostica Stago S.A.S12/23/2022SE
K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingGJS · Special Coagusense, Inc.10/05/2022SE
K213426HemosIL ReadiPlasTinGJS · Traditional Instrumentation Laboratory CO08/16/2022SE
K201185microINR SystemGJS · Traditional Iline Microsystems, S.L.12/18/2020SE

More from Iline Microsystems, S.L.

510(k)DeviceDecision
K000679Thrombostrate Control PlasmasGGN · Traditional 03/24/2000SE
K994100Pacific Hemostasis Thromboplastin DGJS · Traditional 02/18/2000SE
K992130Pacific Hemostasis Thromboscreen 400CKQG · Traditional 09/03/1999SE
K992279Heparin Control Plasma Level 2GGN · Traditional 08/26/1999SE
K992278Heparin Control Plasma Level 1GGN · Traditional 08/26/1999SE
K991321Pacific Hemostasis Thromboscreen 200KQG · Traditional 06/21/1999SE
K990046Pacific Hemostasis Immunodepleted Factor Viii Deficient PlasmaGJT · Traditional 02/17/1999SE
K984131Coagulation Control Level 3 (Abnormal)GGC · Traditional 12/01/1998SE
K984130Coagulation Control Level 2 (Abnormal)GGC · Traditional 12/01/1998SE
K984129Coagulation Control Level 1 (Normal)GIZ · Traditional 12/01/1998SE

Questions and answers

When was Thromboplastin cleared by the FDA?

Thromboplastin (K810350) received a 510(k) decision of Substantially Equivalent on April 14, 1981, 63 days after the submission was received.

What is the product code of K810350?

The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.