Cleared Traditional

ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER

K973938 · Sfri, Inc. · Chemistry

Feb 1998

Decision

112d

Days

Class 1

Risk

About This 510(k) Submission

K973938 is an FDA 510(k) clearance for the ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Sfri, Inc. (Irvine, US). The FDA issued a Cleared decision on February 4, 1998, 112 days after receiving the submission on October 15, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number	K973938 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 1997
Decision Date	February 04, 1998
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement