CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE)— 510(k) K901229

Name: FDA 510(k) clearance K901229
Creator: U.S. Food and Drug Administration
Published: 1990-05-04

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K901229 for CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE), Substantially Equivalent on 1990-05-04. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1990-03-14
Decision date: 1990-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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