510(k) Report

510(k) · Cleared

Cleared

Liquitrol, Liquid Human Glycosyla,Ted Hemoglobin (A1C) Control - Normal/Abnormal

K023032510(k) TraditionalCleared Oct 8, 200227-day reviewClass II21 CFR 864.8625

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bioresource Technology, Inc. · GFS Standards And Controls, Hemoglobin, Normal And Abnormal

Cleared on Oct 8, 2002 after a 27-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Oct 8, 2002
Review
27 days
Class
Class II
Product code
GFS
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K023032Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GFS devices

GFS Standards And Controls, Hemoglobin, Normal And Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GFS

FDA has decided no GFS device since 2007.

Median 510(k) review, days · GFS

Too few GFS 510(k)s in any year since 2007 to give a median.

Recalls per year · GFS

No recall names GFS since 2007.

Adverse event reports per year · GFS

No MAUDE report names GFS since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

Liquid Human Glycosylated Hemoglobin (AIC) Control is intended for use in the laboratory to monitor the precission and accuracy of Glycosylated Hemoglobin (AlC) assay procedures for the methods listed in the package insert. The routine use of quality control materials is an integral part of ensuring the accuracy and precision of laboratory analyses.

Indications for use as stated in the FDA 510(k) statement.

More from Bioresource Technology, Inc.

4 FDA decisions under this applicant name. See the company

  • K060850Nod Chemistry ControlBioresource Technology, Inc. · 2006
  • K040352Nova-One Lipid Control (Special Low Interference Liquid Lipid Control)Bioresource Technology, Inc. · 2004
  • K944728Bioresource Technology Liquichemtrol-Normal Liquid Heman Protein Electrophoresis ControlBioresource Technology, Inc. · 1995

https://510kreport.com/device/K023032 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023032: Liquitrol, Liquid Human Glycosyla,Ted Hemoglobin (A1C) Control - Normal/Abnormal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023032

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026