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FDA 510(k)

PRIMUS MODEL CLC 330

K-Number: K891235 · 1989-06-16

ApplicantPrimus, Inc.
Decision Date1989-06-16
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PRIMUS MODEL CLC 330 is the device name listed in this FDA 510(k) record. The listed applicant is Primus, Inc.. It received FDA 510(k) clearance on 1989-06-16 under 510(k) number K891235. 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 MODEL CLC 330?

PRIMUS MODEL CLC 330 is a medical device that received FDA 510(k) clearance on 1989-06-16. The listed applicant is Primus, Inc.. The 510(k) number is K891235.

When did PRIMUS MODEL CLC 330 receive FDA 510(k) clearance?

PRIMUS MODEL CLC 330 received FDA 510(k) clearance on 1989-06-16, under 510(k) number K891235.

Who is the listed applicant for PRIMUS MODEL CLC 330?

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 PRIMUS MODEL CLC 330?

The FDA product code for PRIMUS MODEL CLC 330 is LCP.

Related Clinical Trials

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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Other records listing Primus, Inc. as applicant

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.

K993131NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAYK896582DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM)

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.

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies ASK192987Aina HbA1c Monitoring System 2Jana Care, Inc.K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.K183230OneDraw A1C Test SystemDrawbridge Health, Inc.

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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