510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023032Substantially Equivalent

Liquitrol, Liquid Human Glycosyla,ted Hemoglobin (A1c) Control - Normal/abnormal

Bioresource Technology, Fort Lauderdale FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K023032 is the FDA 510(k) clearance record for LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL, a class II device, cleared for Bioresource Technology, Inc. on under FDA product code GFS (Standards And Controls, Hemoglobin, Normal And Abnormal). FDA records list 4 510(k) clearances for Bioresource Technology, Inc., from to . As of , FDA records show no recalls naming K023032.

Clearance record

Decision date
Received
(27 days to decision)
Product code
GFS Standards And Controls, Hemoglobin, Normal And Abnormal
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Bioresource Technology, Inc. 1531 NW 65th Ave., Fort Lauderdale FL
510(k) summary
Statement
Third party review
No

Clearances, product code GFS

Trailing 12 months

FDA records hold no clearances under product code GFS in the trailing twelve months.

FDA records show no clearances under product code GFS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GFS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260