Cleared Traditional

CALCIUM REAGENT

K971907 · Carolina Liquid Chemistries Corp. · Chemistry
Jun 1997
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K971907 is an FDA 510(k) clearance for the CALCIUM REAGENT, a Cresolphthalein Complexone, Calcium (Class II — Special Controls, product code CIC), submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on June 24, 1997, 32 days after receiving the submission on May 23, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K971907 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 1997
Decision Date June 24, 1997
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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