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RENCTK

by Sorin Biomedica, Fiat, USA, Inc. 510(k)

Active United States

510(k) K800774

Overview

RENCTK is a radioimmunoassay device for angiotensin I and renin, classified under medical specialty clinical chemistry. It is a substantially equivalent device cleared via the traditional 510(k) pathway.

The device is manufactured by Sorin Biomedica, Fiat, USA, Inc., with product code CIB and regulation number 862.1085. It received FDA 510(k) clearance under K800774 on April 21, 1980, and is classified as a Class II medical device.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800774 Date21 Apr 1980ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CIB
Device Class
Class II
Regulation
21 CFR Part 862.1085
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Sorin Biomedica, Fiat, USA, Inc.

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Questions

  • What is the RENCTK device used for?

    The RENCTK device is a radioimmunoassay system designed to measure angiotensin I and renin levels in clinical chemistry settings, aiding in the assessment of the renin-angiotensin system for diagnostic purposes.

  • How was the RENCTK device cleared for market?

    The RENCTK device received FDA 510(k) clearance through the traditional pathway under submission K800774, demonstrating substantial equivalence to a legally marketed predicate device, which allowed its clearance as a Class II medical device on April 21, 1980.

  • Who manufactures the RENCTK device and where is it located?

    The RENCTK device is manufactured by Sorin Biomedica, Fiat, USA, Inc., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States, as indicated in the device registration and clearance records.