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FDA 510(k)

NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY

K-Number: K993131 · 2000-05-22

ApplicantPrimus, Inc.
Decision Date2000-05-22
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Primus, Inc.. It received FDA 510(k) clearance on 2000-05-22 under 510(k) number K993131. 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 NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY?

NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY is a medical device that received FDA 510(k) clearance on 2000-05-22. The listed applicant is Primus, Inc.. The 510(k) number is K993131.

When did NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY receive FDA 510(k) clearance?

NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY received FDA 510(k) clearance on 2000-05-22, under 510(k) number K993131.

Who is the listed applicant for NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY?

The FDA 510(k) record lists Primus, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY?

The FDA product code for NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY is LCP.

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Other records listing Primus, Inc. as applicant

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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