BECKMAN SYNCHRON LACTATE REAGENT— 510(k) K934271

Name: FDA 510(k) clearance K934271
Creator: U.S. Food and Drug Administration
Published: 1993-11-09

Substantially Equivalent

Beckman-Diagnostic Systems Group

FDA 510(k) clearance K934271 for BECKMAN SYNCHRON LACTATE REAGENT, Substantially Equivalent on 1993-11-09. Applicant: Beckman-Diagnostic Systems Group. Device class: 1.

Clearance details

Applicant: Beckman-Diagnostic Systems Group
Product code: Code KHP
Device class: Class 1
Regulation: 21 CFR 862.1450
Advisory panel: Clinical Chemistry
Date received: 1993-08-31
Decision date: 1993-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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