ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM)— 510(k) K880609

Name: FDA 510(k) clearance K880609
Creator: U.S. Food and Drug Administration
Published: 1988-03-16

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K880609 for ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM), Substantially Equivalent on 1988-03-16. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1988-02-12
Decision date: 1988-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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