Cleared Traditional

K902698 - AFFINITY PROLACTIN TEST SYSTEM (FDA 510(k) Clearance)

K902698 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device

Jul 1990

Decision

30d

Days

Class 1

Risk

K902698 is an FDA 510(k) clearance for the AFFINITY PROLACTIN TEST SYSTEM. This device is classified as a Radioimmunoassay, Prolactin (lactogen) (Class I - General Controls, product code CFT).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on July 19, 1990, 30 days after receiving the submission on June 19, 1990.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1625.

Submission Details

510(k) Number	K902698 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 19, 1990
Decision Date	July 19, 1990
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	CFT — Radioimmunoassay, Prolactin (lactogen)
Device Class	Class I - General Controls
CFR Regulation	21 CFR 862.1625