CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO)— 510(k) K901137

Name: FDA 510(k) clearance K901137
Creator: U.S. Food and Drug Administration
Published: 1990-04-12

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K901137 for CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO), Substantially Equivalent on 1990-04-12. Applicant: Technicon Instruments Corp.. Device class: 1.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code CEO
Device class: Class 1
Regulation: 21 CFR 862.1580
Advisory panel: Clinical Chemistry
Date received: 1990-03-12
Decision date: 1990-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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