Cleared Traditional

REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT

K983914 · Corgenix, Inc. · Hematology
Dec 1998
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K983914 is an FDA 510(k) clearance for the REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Corgenix, Inc. (Westminster, US). The FDA issued a Cleared decision on December 22, 1998, 48 days after receiving the submission on November 4, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K983914 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 1998
Decision Date December 22, 1998
Days to Decision 48 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