510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053253Substantially Equivalent

Hemocue Albumin 201 Analyzing System

HemoCue AB, Lake Forest CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053253 is the FDA 510(k) clearance record for HEMOCUE ALBUMIN 201 ANALYZING SYSTEM, a class I device, cleared for Hemocue AB on under FDA product code KQO (Automated Urinalysis System). FDA records list 15 510(k) clearances for Hemocue AB, from to . As of , FDA records show 2 recalls naming K053253.

Clearance record

Decision date
Received
(88 days to decision)
Product code
KQO Automated Urinalysis System
Regulation
21 CFR 862.2900
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Hemocue AB 40 Empire Dr., Lake Forest CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KQO

Trailing 12 months

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

FDA records show no clearances under product code KQO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KQO, 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