Cleared Traditional

IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER

K905215 · Cirrus Diagnostics, Inc. · Chemistry
Jan 1991
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K905215 is an FDA 510(k) clearance for the IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Cirrus Diagnostics, Inc. (Chester, US). The FDA issued a Cleared decision on January 11, 1991, 52 days after receiving the submission on November 20, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K905215 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 1990
Decision Date January 11, 1991
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2300

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