Cleared Traditional

CBI 7520 READER

K961183 · Columbia Bioscience, Inc. · Chemistry
Aug 1996
Decision
129d
Days
Class 1
Risk

About This 510(k) Submission

K961183 is an FDA 510(k) clearance for the CBI 7520 READER, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Columbia Bioscience, Inc. (Frederick, US). The FDA issued a Cleared decision on August 2, 1996, 129 days after receiving the submission on March 26, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K961183 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1996
Decision Date August 02, 1996
Days to Decision 129 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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