Cleared Traditional

ALIZARIN SULFONATE, CALCIUM

K801290 · Union Carbide Corp. · Chemistry
Jun 1980
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K801290 is an FDA 510(k) clearance for the ALIZARIN SULFONATE, CALCIUM, a Alizarin Sulfonate, Calcium (Class II — Special Controls, product code CID), submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1980, 31 days after receiving the submission on May 30, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K801290 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 1980
Decision Date June 30, 1980
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code CID — Alizarin Sulfonate, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145