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FDA 510(k)

GLYCO-SPIN

K-Number: K792086 · 1979-11-30

ApplicantApplied Clinical Research Laboratories
Decision Date1979-11-30
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCO-SPIN is the device name listed in this FDA 510(k) record. The listed applicant is Applied Clinical Research Laboratories. It received FDA 510(k) clearance on 1979-11-30 under 510(k) number K792086. 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-SPIN?

GLYCO-SPIN is a medical device that received FDA 510(k) clearance on 1979-11-30. The listed applicant is Applied Clinical Research Laboratories. The 510(k) number is K792086.

When did GLYCO-SPIN receive FDA 510(k) clearance?

GLYCO-SPIN received FDA 510(k) clearance on 1979-11-30, under 510(k) number K792086.

Who is the listed applicant for GLYCO-SPIN?

The FDA 510(k) record lists Applied Clinical Research Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLYCO-SPIN?

The FDA product code for GLYCO-SPIN is LCP.

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Other records listing Applied Clinical Research Laboratories as applicant

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.

K803186NORMAL AND ELEVATED CONTROL FOR GLYCO.

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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