Cleared Traditional

CALCIUM TEST ITEM NUMBER 65409

K932158 · Em Diagnostic Systems, Inc. · Chemistry
Sep 1993
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K932158 is an FDA 510(k) clearance for the CALCIUM TEST ITEM NUMBER 65409, a Cresolphthalein Complexone, Calcium (Class II — Special Controls, product code CIC), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on September 27, 1993, 146 days after receiving the submission on May 4, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K932158 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1993
Decision Date September 27, 1993
Days to Decision 146 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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