FDA 510(k)

NYCOCARD CRP CONTROL

K-Number: K014084 · 2002-01-07

Decision Date2002-01-07

Product CodeDCK

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

NYCOCARD CRP CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Primus Corp.. It received FDA 510(k) clearance on 2002-01-07 under 510(k) number K014084. 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 CONTROL?

NYCOCARD CRP CONTROL is a medical device that received FDA 510(k) clearance on 2002-01-07. The listed applicant is Primus Corp.. The 510(k) number is K014084.

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

NYCOCARD CRP CONTROL received FDA 510(k) clearance on 2002-01-07, under 510(k) number K014084.

Who is the listed applicant for NYCOCARD CRP CONTROL?

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 CONTROL?

The FDA product code for NYCOCARD CRP CONTROL is DCK.

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Other records listing Primus Corp. as applicant

K062658PRIMUS A1CARE ASSAY K013787NYCOCARD CRP K994045PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 K992921PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II K955283PRIMUS VARIANT SYSTEM PVS99 K942009PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY

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Related Devices (Code: DCK)

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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.