Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HEMOCUE B-HEMOGLOBIN SYSTEM

K-Number: K961312 · 1996-09-24

ApplicantHemocue, Inc.
Decision Date1996-09-24
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCUE B-HEMOGLOBIN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hemocue, Inc.. It received FDA 510(k) clearance on 1996-09-24 under 510(k) number K961312. The device is classified under product code GKR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCUE B-HEMOGLOBIN SYSTEM?

HEMOCUE B-HEMOGLOBIN SYSTEM is a medical device that received FDA 510(k) clearance on 1996-09-24. The listed applicant is Hemocue, Inc.. The 510(k) number is K961312.

When did HEMOCUE B-HEMOGLOBIN SYSTEM receive FDA 510(k) clearance?

HEMOCUE B-HEMOGLOBIN SYSTEM received FDA 510(k) clearance on 1996-09-24, under 510(k) number K961312.

Who is the listed applicant for HEMOCUE B-HEMOGLOBIN SYSTEM?

The FDA 510(k) record lists Hemocue, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOCUE B-HEMOGLOBIN SYSTEM?

The FDA product code for HEMOCUE B-HEMOGLOBIN SYSTEM is GKR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hemocue, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K041234HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEMK041230CLINICAL LABORATORY ANALYZING SYSTEMK032203HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704K020935HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706K962415HEMOCUE B-GLCOSE SYSTEMK961311HEMOCUE B-GLUCOSE SYSTEM

View all 9 devices →

Related Devices (Code: GKR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201217HemoCue Hb 301 SystemHemocue ABK200909Hemo Control (optional Add Pack Hemo Control DM)Ekf-Diagnostic GmbHK181751HemoCue Hb 801 SystemHemocue ABK182298hemochroma PLUS SystemImmunostics Inc.,K172173DiaSpect Tm, DiaSpect Tm CuvettesEkf-Diagnostic GmbHK163465hemochroma PLUS SystemImmunostics Inc.,

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑