Cleared Traditional

K900240 - DELFIA TBG KIT
(FDA 510(k) Clearance)

K900240 · Pharmacia, Inc. · Chemistry

Mar 1990

Decision

72d

Days

Class 2

Risk

K900240 is an FDA 510(k) clearance for the DELFIA TBG KIT, a Radioimmunoassay, Thyroxine-binding Globulin (Class II — Special Controls, product code CEE), submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on March 30, 1990, 72 days after receiving the submission on January 17, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1685.

Submission Details

510(k) Number	K900240 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 1990
Decision Date	March 30, 1990
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—