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510(k) K071017

IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) by Siemens Medical Solutions Diagnostics — Product Code NQD

K071017 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions Diagnostics for the device "IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)". The FDA issued a decision of Substantially Equivalent on May 2, 2007. The device falls under product code NQD (Cardiac C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Siemens Medical Solutions Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2007
Date Received
April 10, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.

Other clearances by Siemens Medical Solutions Diagnostics

  • K100910 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (May 11, 2011)
  • K091984 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (October 28, 2009)
  • K081895 — ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS (January 8, 2009)
  • K071455 — ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR (September 11, 2008)
  • K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 (June 27, 2008)
  • K072658 — ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS (April 1, 2008)
  • K072794 — IMMULITE 2500 OM-MA, MODEL L5KOP (November 5, 2007)
  • K071466 — DCA VANTAGE, MODEL 5075 (October 9, 2007)
  • K072204 — ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS (October 5, 2007)
  • K070727 — ADVIA CHEMISTRY ENZYMATIC CREATININE_2 (August 3, 2007)

Other clearances for product code NQD

  • K260026 — Tina-quant Cardiac high sensitivity CRP III (April 2, 2026)
  • K233242 — Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) (January 18, 2024)
  • K212559 — CardioPhase® hsCRP (December 16, 2022)
  • K173833 — CRP Vario (September 27, 2018)
  • K081294 — ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRA (July 29, 2008)
  • K071002 — IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP (June 21, 2007)
  • K070626 — SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT (May 4, 2007)
  • K062924 — STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK (December 26, 2006)
  • K063057 — IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP (December 22, 2006)
  • K061802 — DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, (September 11, 2006)

FDA data resources