510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212559Substantially Equivalent

CardioPhase® hsCRP

Siemens Healthcare Diagnostics Products Limited, Marburg, DE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212559 is the FDA 510(k) clearance record for CardioPhase® hsCRP, a class II device, cleared for Siemens Healthcare Diagnostics Products GmbH on under FDA product code NQD (Cardiac C-Reactive Protein, Antigen, Antiserum, And Control). FDA's definition for product code NQD reads: "In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments". FDA records list 23 510(k) clearances for Siemens Healthcare Diagnostics Products GmbH, from to . As of , FDA records show no recalls naming K212559.

Clearance record

Decision date
Received
(490 days to decision)
Product code
NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Applicant
Siemens Healthcare Diagnostics Products GmbH Emil-Von-Behring St. 76, Marburg, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQD

Trailing 12 months
1 clearance under product code NQD in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NQD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260