510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961312Substantially Equivalent

Hemocue B-Hemoglobin System

HemoCue AB, Potomac MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961312 is the FDA 510(k) clearance record for HEMOCUE B-HEMOGLOBIN SYSTEM, a class II device, cleared for Hemocue, Inc. on under FDA product code GKR (System, Hemoglobin, Automated). FDA records list 15 510(k) clearances for Hemocue, Inc., from to . As of , FDA records show no recalls naming K961312.

Clearance record

Decision date
Received
(173 days to decision)
Product code
GKR System, Hemoglobin, Automated
Regulation
21 CFR 864.5620
Device class
Class II
Review panel
Hematology
Applicant
Hemocue, Inc. C/O Robert Joel Slomof, Potomac MD
510(k) summary
Statement
Third party review
No

Clearances, product code GKR

Trailing 12 months

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

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