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FDA 510(k)

HEMOGLOBIN REAGENT

K-Number: K831618 · 1983-06-16

ApplicantOmega Medical Diagnostics
Decision Date1983-06-16
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Diagnostics. It received FDA 510(k) clearance on 1983-06-16 under 510(k) number K831618. 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 HEMOGLOBIN REAGENT?

HEMOGLOBIN REAGENT is a medical device that received FDA 510(k) clearance on 1983-06-16. The listed applicant is Omega Medical Diagnostics. The 510(k) number is K831618.

When did HEMOGLOBIN REAGENT receive FDA 510(k) clearance?

HEMOGLOBIN REAGENT received FDA 510(k) clearance on 1983-06-16, under 510(k) number K831618.

Who is the listed applicant for HEMOGLOBIN REAGENT?

The FDA 510(k) record lists Omega Medical Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOGLOBIN REAGENT?

The FDA product code for HEMOGLOBIN REAGENT 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 Omega Medical Diagnostics 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.

K832182LYSING REAGENTK831619SODIUM HYPOCHLORITE 7%K831620SODIUM HYPOCHLORITE 3%K831617DILUENT

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.

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