Cleared Traditional

CALCIUM, SCAL, NORTROL, ABTROL

K073355 · Thermofisher Scientific OY · Chemistry
Feb 2008
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K073355 is an FDA 510(k) clearance for the CALCIUM, SCAL, NORTROL, ABTROL, a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by Thermofisher Scientific OY (Vantaa, FI). The FDA issued a Cleared decision on February 28, 2008, 91 days after receiving the submission on November 29, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K073355 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2007
Decision Date February 28, 2008
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJY — Azo Dye, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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