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FDA 510(k)

LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT

K-Number: K791103 · 1979-06-28

ApplicantLeeco Diagnostics, Inc.
Decision Date1979-06-28
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Leeco Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-06-28 under 510(k) number K791103. 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 LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT?

LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1979-06-28. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K791103.

When did LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT receive FDA 510(k) clearance?

LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT received FDA 510(k) clearance on 1979-06-28, under 510(k) number K791103.

Who is the listed applicant for LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT?

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

What is the FDA product code for LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT?

The FDA product code for LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT 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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