Cleared Traditional

K840757 - ELVI 444 BILITRON
(FDA 510(k) Clearance)

K840757 · Logos Scientific, Inc. · Chemistry

May 1984

Decision

97d

Days

Class 2

Risk

K840757 is an FDA 510(k) clearance for the ELVI 444 BILITRON, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Logos Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 30, 1984, 97 days after receiving the submission on February 23, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number	K840757 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 1984
Decision Date	May 30, 1984
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—