Cleared Traditional

MODIFIED DELFIA ESTRADIOL KIT

K902358 · Pharmacia, Inc. · Chemistry
Jun 1990
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K902358 is an FDA 510(k) clearance for the MODIFIED DELFIA ESTRADIOL KIT, a Radioimmunoassay, Estradiol (Class I — General Controls, product code CHP), submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on June 18, 1990, 20 days after receiving the submission on May 29, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1260.

Submission Details

510(k) Number K902358 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1990
Decision Date June 18, 1990
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHP — Radioimmunoassay, Estradiol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1260

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