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Renin Radioimmunoassay Test Kit

by Serono Diagnostics, Inc.

510(k) K842966

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK842966 Date11 Oct 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Renin Radioimmunoassay Test Kit is a device intended to measure the level of angiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension. This test system operates as a radioimmunoassay, utilizing radioactive materials to detect and quantify specific substances in blood samples.

The kit is supplied by Serono Diagnostics, Inc. and is classified under product code CIB for radioimmunoassay of angiotensin I and renin. It received FDA 510(k) clearance on October 11, 1984, with the device number K842966. The device is intended for laboratory use and requires appropriate handling of radioactive components as specified in the manufacturer's instructions.

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