ABX PENTRA TPU CAL, MODEL A11A01898— 510(k) K092570

Name: FDA 510(k) clearance K092570
Creator: U.S. Food and Drug Administration
Published: 2009-10-16

Substantially Equivalent

HORIBA ABX SAS

FDA 510(k) clearance K092570 for ABX PENTRA TPU CAL, MODEL A11A01898, Substantially Equivalent on 2009-10-16. Applicant: HORIBA ABX SAS. Device class: 2.

Clearance details

Applicant: HORIBA ABX SAS
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2009-08-21
Decision date: 2009-10-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Montpellier, FR

Download summary PDF View on FDA.gov ↗

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