Cleared Traditional

ANTHOS PHACTS VERSION MICROPLATE READER

K962113 · Columbia Bioscience, Inc. · Chemistry
Nov 1996
Decision
158d
Days
Class 1
Risk

About This 510(k) Submission

K962113 is an FDA 510(k) clearance for the ANTHOS PHACTS VERSION MICROPLATE 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 November 5, 1996, 158 days after receiving the submission on May 31, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K962113 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1996
Decision Date November 05, 1996
Days to Decision 158 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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