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FDA 510(k)

PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2

K-Number: K994045 · 1999-12-21

ApplicantPrimus Corp.
Decision Date1999-12-21
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 is the device name listed in this FDA 510(k) record. The listed applicant is Primus Corp.. It received FDA 510(k) clearance on 1999-12-21 under 510(k) number K994045. 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 LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2?

PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 is a medical device that received FDA 510(k) clearance on 1999-12-21. The listed applicant is Primus Corp.. The 510(k) number is K994045.

When did PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 receive FDA 510(k) clearance?

PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 received FDA 510(k) clearance on 1999-12-21, under 510(k) number K994045.

Who is the listed applicant for PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2?

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 LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2?

The FDA product code for PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 is LCP.

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Other records listing Primus Corp. 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.

K062658PRIMUS A1CARE ASSAYK013787NYCOCARD CRPK014084NYCOCARD CRP CONTROLK992921PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL IIK955283PRIMUS VARIANT SYSTEM PVS99K942009PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY

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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.

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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