Cleared Traditional

K032482 - STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
(FDA 510(k) Clearance)

K032482 · Stanbio Laboratory · Hematology device

Oct 2003

Decision

73d

Days

Class 2

Risk

K032482 is an FDA 510(k) clearance for the STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM. This device is classified as a System, Hemoglobin, Automated (Class II - Special Controls, product code GKR).

Submitted by Stanbio Laboratory (Boerne, US). The FDA issued a Cleared decision on October 24, 2003, 73 days after receiving the submission on August 12, 2003.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number	K032482 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 12, 2003
Decision Date	October 24, 2003
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF