Rapitex (R) Crp New

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K903853 ↗

FDA Product Code

DCN

Device Class

Class II

Regulation

21 CFR Part 866.5270

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Clibration Plasmas

  Class II

  FDA 510(k) K924404 Active Cleared 1 Dec 1992

• Opus Ck-Mb & Total Ck Controls

  Class I

  FDA 510(k) K960275 Active Cleared 25 Apr 1996

• D.A.T. (Tm) Amylase Reagent

  Class II

  FDA 510(k) K871943 Active Cleared 3 Jun 1987

• N/T Protein Control Sl

  Class I

  FDA 510(k) K964065 Active Cleared 6 Nov 1996

• Enzygnost(R) Anti-Cmv Igg

  Class II

  FDA 510(k) K913910 Active Cleared 28 Apr 1992

• N/T Rheumatology Control Sl/1 and Sl/2

  Class II

  FDA 510(k) K962373 Active Cleared 11 Jul 1996

See all devices from Behring Diagnostics, Inc. →

• What is the RAPITEX CRP NEW used for?

  The RAPITEX CRP NEW is used for immunology testing to measure C-reactive protein levels in patient samples, as stated in its description as a System, Test, C-Reactive Protein device.

• Who manufactures the RAPITEX CRP NEW and where are they located?

  The RAPITEX CRP NEW is manufactured by Behring Diagnostics, Inc., located at 17 Chubb Way, Somerville, NJ 08876, based on the manufacturer and address details in the device data.

• What regulatory pathway was used for the RAPITEX CRP NEW and when was it cleared?

  The RAPITEX CRP NEW received FDA 510(k) clearance through a traditional submission on August 30, 1990, with K-number K903853 and product code DCN, as specified in the authorizations and specifications sections.

• What class of medical device is the RAPITEX CRP NEW and what specialty does it belong to?

  The RAPITEX CRP NEW is a Class II medical device with special controls, falling under the immunology medical specialty, as indicated by its device class, regulation number, and advisory committee description.