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FDA 510(k)

GLYCOSYLATED HEMOGLOBIN-SMC COLUMN

K-Number: K802233 · 1980-10-10

ApplicantHelena Laboratories
Decision Date1980-10-10
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCOSYLATED HEMOGLOBIN-SMC COLUMN is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802233. 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 GLYCOSYLATED HEMOGLOBIN-SMC COLUMN?

GLYCOSYLATED HEMOGLOBIN-SMC COLUMN is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Helena Laboratories. The 510(k) number is K802233.

When did GLYCOSYLATED HEMOGLOBIN-SMC COLUMN receive FDA 510(k) clearance?

GLYCOSYLATED HEMOGLOBIN-SMC COLUMN received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802233.

Who is the listed applicant for GLYCOSYLATED HEMOGLOBIN-SMC COLUMN?

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 GLYCOSYLATED HEMOGLOBIN-SMC COLUMN?

The FDA product code for GLYCOSYLATED HEMOGLOBIN-SMC COLUMN is LCP.

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Related Devices (Code: LCP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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