Cleared Traditional

HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801

K061047 · Hemocue AB · Hematology

Jun 2006

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K061047 is an FDA 510(k) clearance for the HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801, a System, Hemoglobin, Automated (Class II — Special Controls, product code GKR), submitted by Hemocue AB (Lake Forest, US). The FDA issued a Cleared decision on June 8, 2006, 55 days after receiving the submission on April 14, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number	K061047 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2006
Decision Date	June 08, 2006
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF