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FDA 510(k)

GLYCOHEMOGLOBIN IN WHOLE BLOOD

K-Number: K802721 · 1980-12-11

ApplicantSigma Chemical Co.
Decision Date1980-12-11
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCOHEMOGLOBIN IN WHOLE BLOOD is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1980-12-11 under 510(k) number K802721. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLYCOHEMOGLOBIN IN WHOLE BLOOD?

GLYCOHEMOGLOBIN IN WHOLE BLOOD is a medical device that received FDA 510(k) clearance on 1980-12-11. The listed applicant is Sigma Chemical Co.. The 510(k) number is K802721.

When did GLYCOHEMOGLOBIN IN WHOLE BLOOD receive FDA 510(k) clearance?

GLYCOHEMOGLOBIN IN WHOLE BLOOD received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802721.

Who is the listed applicant for GLYCOHEMOGLOBIN IN WHOLE BLOOD?

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

What is the FDA product code for GLYCOHEMOGLOBIN IN WHOLE BLOOD?

The FDA product code for GLYCOHEMOGLOBIN IN WHOLE BLOOD is LCP.

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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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