Cleared Traditional

CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)

K901226 · Technicon Instruments Corp. · Chemistry
Apr 1990
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K901226 is an FDA 510(k) clearance for the CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM), a Cresolphthalein Complexone, Calcium (Class II — Special Controls, product code CIC), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on April 19, 1990, 36 days after receiving the submission on March 14, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K901226 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 1990
Decision Date April 19, 1990
Days to Decision 36 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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