Cleared Traditional

DELFIA PLATE FLUOROMETER 1232

K895240 · Pharmacia, Inc. · Chemistry
Oct 1989
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K895240 is an FDA 510(k) clearance for the DELFIA PLATE FLUOROMETER 1232, a Fluorometer, For Clinical Use (Class I — General Controls, product code KHO), submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on October 4, 1989, 44 days after receiving the submission on August 21, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2560.

Submission Details

510(k) Number K895240 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1989
Decision Date October 04, 1989
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KHO — Fluorometer, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2560

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