QEA SODIUM/POTASSIUM ANALYZER— 510(k) K833776

Name: FDA 510(k) clearance K833776
Creator: U.S. Food and Drug Administration
Published: 1983-12-29

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K833776 for QEA SODIUM/POTASSIUM ANALYZER, Substantially Equivalent on 1983-12-29. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1983-10-27
Decision date: 1983-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEM

view all

K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions2026-02-12
K241037 — ABL90 FLEX PLUS System2025-01-14
K220396 — EasyStat 3002023-09-26
K230890 — ISE Electrodes2023-09-08
K200544 — SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+2020-10-01

More clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic

view all

K003062 — BACTEC MGIT 960 SIR KITS2001-06-06
K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE2001-03-21
K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE2001-02-01
K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/162000-11-29
K001364 — BD DIRECTIGEN FLU A+B2000-06-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.