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FDA 510(k)

DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY

K-Number: K882222 · 1988-08-01

ApplicantBio-Rad
Decision Date1988-08-01
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1988-08-01 under 510(k) number K882222. 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 DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY?

DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY is a medical device that received FDA 510(k) clearance on 1988-08-01. The listed applicant is Bio-Rad. The 510(k) number is K882222.

When did DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY receive FDA 510(k) clearance?

DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY received FDA 510(k) clearance on 1988-08-01, under 510(k) number K882222.

Who is the listed applicant for DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY?

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 DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY?

The FDA product code for DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY 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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