Cleared Traditional

CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO)

K901137 · Technicon Instruments Corp. · Chemistry
Apr 1990
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K901137 is an FDA 510(k) clearance for the CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO), a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on April 12, 1990, 31 days after receiving the submission on March 12, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1580.

Submission Details

510(k) Number K901137 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 1990
Decision Date April 12, 1990
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CEO — Phosphomolybdate (colorimetric), Inorganic Phosphorus
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1580

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