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Fibrinogen Control

by Sigma Diagnostics, Inc. 510(k)

Active United States

510(k) K915462

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK915462 Date4 Mar 1992ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GIL
Device Class
Class II
Regulation
21 CFR Part 864.7340
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Fibrinogen Control is a plasma‑based control material used to verify the performance of fibrinogen assays in hematology testing. It provides a known reference value to ensure accurate measurement of fibrinogen concentrations in patient samples.

The product is marketed by Sigma Diagnostics, Inc. and is classified as a Class II device (product code GIL) with FDA 510(k) clearance (K915462) issued on March 4 1992. It is supplied as a single‑use control reagent, intended for use in laboratory settings under the special controls applicable to plasma fibrinogen controls.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is Fibrinogen Control used for?

    Fibrinogen Control is used to verify the performance of fibrinogen assays in hematology testing by providing a known reference value that ensures accurate measurement of fibrinogen concentrations in patient samples.

  • How is Fibrinogen Control supplied and is it reusable?

    Fibrinogen Control is supplied as a single-use control reagent, meaning it is intended for one-time use only and should not be reused to maintain assay integrity and prevent contamination.

  • What type of material is Fibrinogen Control made from and where is it used?

    Fibrinogen Control is a plasma-based control material designed for use in laboratory settings to support hematology testing, specifically for verifying fibrinogen assay performance.