Cleared Traditional

TRIAGE PROTEIN C TEST

K062530 · Biosite Incorporated · Hematology
Jan 2007
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K062530 is an FDA 510(k) clearance for the TRIAGE PROTEIN C TEST, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Biosite Incorporated (San Deigo, US). The FDA issued a Cleared decision on January 29, 2007, 153 days after receiving the submission on August 29, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K062530 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2006
Decision Date January 29, 2007
Days to Decision 153 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGP — Test, Qualitative And Quantitative Factor Deficiency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

Similar Devices — GGP Test, Qualitative And Quantitative Factor Deficiency

All 189
CRYOcheck Chromogenic Factor VIII
K251440 · Precision Biologic, Inc. · Aug 2025
HemosIL Chromogenic Factor IX
K230852 · Instrumentation Laboratory Company · Dec 2023
vWF Ag
K220728 · Siemens Healthcare Diagnostics Products GmbH · Jun 2023
CRYOcheck Chromogenic Factor IX
K214002 · Precision Biologic, Inc. · Dec 2022
HemosIL von Willebrand Factor Antigen
K223402 · Instrumentation Laboratory CO · Dec 2022
HemosIL von Willebrand Factor Antigen
K200033 · Instrumentation Laboratory CO · Aug 2020