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510(k) K014084

NYCOCARD CRP CONTROL by Primus Corp. — Product Code DCK

K014084 is an FDA 510(k) premarket notification submitted by Primus Corp. for the device "NYCOCARD CRP CONTROL". The FDA issued a decision of Substantially Equivalent on January 7, 2002. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Primus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2002
Date Received
December 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

Other clearances by Primus Corp.

  • K062658 — PRIMUS A1CARE ASSAY (November 26, 2007)
  • K013787 — NYCOCARD CRP (May 14, 2002)
  • K993131 — NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY (May 22, 2000)
  • K994045 — PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 (December 21, 1999)
  • K992921 — PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II (November 12, 1999)
  • K955283 — PRIMUS VARIANT SYSTEM PVS99 (March 1, 1996)
  • K942009 — PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY (September 14, 1994)
  • K940008 — GLYCATED PROTEIN CALIBRATORS (May 9, 1994)
  • K940142 — GLYCATED PROTEIN CONTROLS (April 26, 1994)
  • K936204 — GLYCATED HEMOGLOBIN CALIBRATORS (March 22, 1994)

Other clearances for product code DCK

  • K242170 — K-ASSAY CRP (Ver.2) (April 18, 2025)
  • K201256 — Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge (November 4, 2022)
  • K192028 — Yumizen C1200 CRP (June 25, 2020)
  • K192118 — CRP Vario (November 8, 2019)
  • K191993 — Yumizen C1200 CRP (October 3, 2019)
  • K160712 — VITROS Chemistry Products hsCRP Reagent (July 14, 2017)
  • K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, (March 10, 2016)
  • K152433 — VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (September 24, 2015)
  • K141689 — FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Rea (January 7, 2015)
  • K121558 — DIAZYME HSCRP POC TEST KIT (September 21, 2012)

FDA data resources