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FDA 510(k)

LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II

K-Number: K862186 · 1986-07-01

ApplicantBio-Rad
Decision Date1986-07-01
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1986-07-01 under 510(k) number K862186. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II?

LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II is a medical device that received FDA 510(k) clearance on 1986-07-01. The listed applicant is Bio-Rad. The 510(k) number is K862186.

When did LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II receive FDA 510(k) clearance?

LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II received FDA 510(k) clearance on 1986-07-01, under 510(k) number K862186.

Who is the listed applicant for LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II?

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 GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II?

The FDA product code for LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II is JPK.

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Related Devices (Code: JPK)

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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