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FDA 510(k)

HEMOGLOBIN REAGENT

K-Number: K910745 · 1991-07-11

ApplicantToa Medical Electronics USA, Inc.
Decision Date1991-07-11
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 Toa Medical Electronics USA, Inc.. It received FDA 510(k) clearance on 1991-07-11 under 510(k) number K910745. 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 1991-07-11. The listed applicant is Toa Medical Electronics USA, Inc.. The 510(k) number is K910745.

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

HEMOGLOBIN REAGENT received FDA 510(k) clearance on 1991-07-11, under 510(k) number K910745.

Who is the listed applicant for HEMOGLOBIN REAGENT?

The FDA 510(k) record lists Toa Medical Electronics USA, Inc. 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.

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Other records listing Toa Medical Electronics USA, Inc. as applicant

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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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