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FDA 510(k)

HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)

K-Number: K862371 · 1986-09-16

ApplicantBio-Rad
Decision Date1986-09-16
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C) is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1986-09-16 under 510(k) number K862371. 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 HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)?

HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C) is a medical device that received FDA 510(k) clearance on 1986-09-16. The listed applicant is Bio-Rad. The 510(k) number is K862371.

When did HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C) receive FDA 510(k) clearance?

HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C) received FDA 510(k) clearance on 1986-09-16, under 510(k) number K862371.

Who is the listed applicant for HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)?

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 HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)?

The FDA product code for HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C) is LCP.

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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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