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FDA 510(k)

NORMAL AND ELEVATED CONTROL FOR GLYCO.

K-Number: K803186 · 1981-01-21

ApplicantApplied Clinical Research Laboratories
Decision Date1981-01-21
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

NORMAL AND ELEVATED CONTROL FOR GLYCO. 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 1981-01-21 under 510(k) number K803186. 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 NORMAL AND ELEVATED CONTROL FOR GLYCO.?

NORMAL AND ELEVATED CONTROL FOR GLYCO. is a medical device that received FDA 510(k) clearance on 1981-01-21. The listed applicant is Applied Clinical Research Laboratories. The 510(k) number is K803186.

When did NORMAL AND ELEVATED CONTROL FOR GLYCO. receive FDA 510(k) clearance?

NORMAL AND ELEVATED CONTROL FOR GLYCO. received FDA 510(k) clearance on 1981-01-21, under 510(k) number K803186.

Who is the listed applicant for NORMAL AND ELEVATED CONTROL FOR GLYCO.?

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 NORMAL AND ELEVATED CONTROL FOR GLYCO.?

The FDA product code for NORMAL AND ELEVATED CONTROL FOR GLYCO. 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.

K792086GLYCO-SPIN

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

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