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FDA 510(k)

GLYCO-TEK AFFINITY COLUMN

K-Number: K842689 · 1984-10-15

ApplicantHelena Laboratories
Decision Date1984-10-15
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCO-TEK AFFINITY 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 1984-10-15 under 510(k) number K842689. 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-TEK AFFINITY COLUMN?

GLYCO-TEK AFFINITY COLUMN is a medical device that received FDA 510(k) clearance on 1984-10-15. The listed applicant is Helena Laboratories. The 510(k) number is K842689.

When did GLYCO-TEK AFFINITY COLUMN receive FDA 510(k) clearance?

GLYCO-TEK AFFINITY COLUMN received FDA 510(k) clearance on 1984-10-15, under 510(k) number K842689.

Who is the listed applicant for GLYCO-TEK AFFINITY 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 GLYCO-TEK AFFINITY COLUMN?

The FDA product code for GLYCO-TEK AFFINITY COLUMN is LCP.

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Related Devices (Code: 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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