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FDA 510(k)

PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY

K-Number: K942009 · 1994-09-14

ApplicantPrimus Corp.
Decision Date1994-09-14
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Primus Corp.. It received FDA 510(k) clearance on 1994-09-14 under 510(k) number K942009. 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 PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY?

PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY is a medical device that received FDA 510(k) clearance on 1994-09-14. The listed applicant is Primus Corp.. The 510(k) number is K942009.

When did PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY receive FDA 510(k) clearance?

PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY received FDA 510(k) clearance on 1994-09-14, under 510(k) number K942009.

Who is the listed applicant for PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY?

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

What is the FDA product code for PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY?

The FDA product code for PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY 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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