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FDA 510(k)

NYCOCARD CRP

K-Number: K013787 · 2002-05-14

ApplicantPrimus Corp.
Decision Date2002-05-14
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NYCOCARD CRP is the device name listed in this FDA 510(k) record. The listed applicant is Primus Corp.. It received FDA 510(k) clearance on 2002-05-14 under 510(k) number K013787. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NYCOCARD CRP?

NYCOCARD CRP is a medical device that received FDA 510(k) clearance on 2002-05-14. The listed applicant is Primus Corp.. The 510(k) number is K013787.

When did NYCOCARD CRP receive FDA 510(k) clearance?

NYCOCARD CRP received FDA 510(k) clearance on 2002-05-14, under 510(k) number K013787.

Who is the listed applicant for NYCOCARD CRP?

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 NYCOCARD CRP?

The FDA product code for NYCOCARD CRP is DCK.

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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 ASSAYK014084NYCOCARD CRP CONTROLK994045PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2K992921PRIMUS 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: DCK)

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.

K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLCK201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise DiagnosticsK192028Yumizen C1200 CRPHORIBA ABX SASK192118CRP VarioSENTINEL CH. SpAK191993Yumizen C1200 CRPHORIBA ABX SASK160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics

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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