Cleared Traditional

GEN-PROBE LUMINOMETER-LEADER 450

K905762 · Gen-Probe, Inc. · Chemistry
Jan 1991
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K905762 is an FDA 510(k) clearance for the GEN-PROBE LUMINOMETER-LEADER 450, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on January 23, 1991, 27 days after receiving the submission on December 27, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K905762 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1990
Decision Date January 23, 1991
Days to Decision 27 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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