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Centria Hpl Ria

by Union Carbide Corp. 510(k)

Active United States

510(k) K791854

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK791854 Date1 Oct 1979ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
JMF
Device Class
Class II
Regulation
21 CFR Part 862.1585
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

Radioimmunoassay, Human Placental Lactogen is a device used in clinical chemistry for the quantitative measurement of human placental lactogen in serum or plasma specimens. It operates as a radioimmunoassay system to detect and quantify this specific hormone.

The device is supplied as a traditional 510(k) cleared in vitro diagnostic reagent system, classified as Class II under regulation number 862.1585 with product code JMF. It received FDA 510(k) clearance K791854 on October 1, 1979, and is intended for use in clinical laboratory settings.

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