Cleared Traditional

CALCIUM DYE REAGENT-CS-718-A/BUFFER

K833035 · Fisher Scientific Co., LLC · Chemistry
Nov 1983
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K833035 is an FDA 510(k) clearance for the CALCIUM DYE REAGENT-CS-718-A/BUFFER, a Cresolphthalein Complexone, Calcium (Class II — Special Controls, product code CIC), submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on November 3, 1983, 57 days after receiving the submission on September 7, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K833035 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 1983
Decision Date November 03, 1983
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CIC — Cresolphthalein Complexone, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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