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FDA 510(k)

SYSING AND HEMOGLOBIN REAGENT

K-Number: K780829 · 1978-06-22

ApplicantHarleco
Decision Date1978-06-22
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSING AND HEMOGLOBIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1978-06-22 under 510(k) number K780829. 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 SYSING AND HEMOGLOBIN REAGENT?

SYSING AND HEMOGLOBIN REAGENT is a medical device that received FDA 510(k) clearance on 1978-06-22. The listed applicant is Harleco. The 510(k) number is K780829.

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

SYSING AND HEMOGLOBIN REAGENT received FDA 510(k) clearance on 1978-06-22, under 510(k) number K780829.

Who is the listed applicant for SYSING AND HEMOGLOBIN REAGENT?

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

What is the FDA product code for SYSING AND HEMOGLOBIN REAGENT?

The FDA product code for SYSING AND HEMOGLOBIN REAGENT is GKR.

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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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