ABBOTT SPECTRUM(R) BICARBONATE REAGENT— 510(k) K884821

Name: FDA 510(k) clearance K884821
Creator: U.S. Food and Drug Administration
Published: 1988-12-27

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K884821 for ABBOTT SPECTRUM(R) BICARBONATE REAGENT, Substantially Equivalent on 1988-12-27. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1988-11-17
Decision date: 1988-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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