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FDA 510(k)

GLYCO HB QUIK COLUMN PROCEDURE

K-Number: K823869 · 1983-02-01

ApplicantHelena Laboratories
Decision Date1983-02-01
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCO HB QUIK COLUMN PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1983-02-01 under 510(k) number K823869. 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 GLYCO HB QUIK COLUMN PROCEDURE?

GLYCO HB QUIK COLUMN PROCEDURE is a medical device that received FDA 510(k) clearance on 1983-02-01. The listed applicant is Helena Laboratories. The 510(k) number is K823869.

When did GLYCO HB QUIK COLUMN PROCEDURE receive FDA 510(k) clearance?

GLYCO HB QUIK COLUMN PROCEDURE received FDA 510(k) clearance on 1983-02-01, under 510(k) number K823869.

Who is the listed applicant for GLYCO HB QUIK COLUMN PROCEDURE?

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 GLYCO HB QUIK COLUMN PROCEDURE?

The FDA product code for GLYCO HB QUIK COLUMN PROCEDURE 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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