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FDA 510(k)

LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN

K-Number: K831478 · 1983-06-22

ApplicantBio-Rad
Decision Date1983-06-22
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1983-06-22 under 510(k) number K831478. 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 LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN?

LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN is a medical device that received FDA 510(k) clearance on 1983-06-22. The listed applicant is Bio-Rad. The 510(k) number is K831478.

When did LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN receive FDA 510(k) clearance?

LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN received FDA 510(k) clearance on 1983-06-22, under 510(k) number K831478.

Who is the listed applicant for LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN?

The FDA product code for LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN 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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