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FDA 510(k)

HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.

K-Number: K803016 · 1980-12-30

ApplicantHelena Laboratories
Decision Date1980-12-30
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HELENA HEMESPEC II TOTAL HEMOGLOBIN MET. is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1980-12-30 under 510(k) number K803016. 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 HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.?

HELENA HEMESPEC II TOTAL HEMOGLOBIN MET. is a medical device that received FDA 510(k) clearance on 1980-12-30. The listed applicant is Helena Laboratories. The 510(k) number is K803016.

When did HELENA HEMESPEC II TOTAL HEMOGLOBIN MET. receive FDA 510(k) clearance?

HELENA HEMESPEC II TOTAL HEMOGLOBIN MET. received FDA 510(k) clearance on 1980-12-30, under 510(k) number K803016.

Who is the listed applicant for HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.?

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

What is the FDA product code for HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.?

The FDA product code for HELENA HEMESPEC II TOTAL HEMOGLOBIN MET. is GKR.

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Other records listing Helena Laboratories as applicant

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Related Devices (Code: 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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