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FDA 510(k)

PREMIER HB9210 HBA1C ANALYZER

K-Number: K112015 · 2011-11-22

ApplicantPrimus Corporation Dba Trinity Biotech
Decision Date2011-11-22
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PREMIER HB9210 HBA1C ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Primus Corporation Dba Trinity Biotech. It received FDA 510(k) clearance on 2011-11-22 under 510(k) number K112015. 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 PREMIER HB9210 HBA1C ANALYZER?

PREMIER HB9210 HBA1C ANALYZER is a medical device that received FDA 510(k) clearance on 2011-11-22. The listed applicant is Primus Corporation Dba Trinity Biotech. The 510(k) number is K112015.

When did PREMIER HB9210 HBA1C ANALYZER receive FDA 510(k) clearance?

PREMIER HB9210 HBA1C ANALYZER received FDA 510(k) clearance on 2011-11-22, under 510(k) number K112015.

Who is the listed applicant for PREMIER HB9210 HBA1C ANALYZER?

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

What is the FDA product code for PREMIER HB9210 HBA1C ANALYZER?

The FDA product code for PREMIER HB9210 HBA1C ANALYZER 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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