AVL 988-4 ELECTROLYTE ANALYZER— 510(k) K943702

Name: FDA 510(k) clearance K943702
Creator: U.S. Food and Drug Administration
Published: 1994-09-09

Substantially Equivalent

Avl Scientific Corp.

FDA 510(k) clearance K943702 for AVL 988-4 ELECTROLYTE ANALYZER, Substantially Equivalent on 1994-09-09. Applicant: Avl Scientific Corp.. Device class: 2.

Clearance details

Applicant: Avl Scientific Corp.
Product code: Code JFP
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 1994-07-29
Decision date: 1994-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JFP

view all

K230300 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
K191360 — i-STAT CHEM8+ cartridge with the i-STAT 1 System2020-02-14
K191626 — Stat Profile Prime ES Comp Plus Analyzer System2019-08-16
K152327 — EasyLyte Na/K/Cl/Ca Analyzer2016-12-01
K984299 — AVL OPTI CRITICAL CARE ANALYZER1998-12-11

More clearances from Avl Scientific Corp.

view all

K001632 — OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC70092000-06-19
K000103 — AVL OPTI R ANALYZER2000-03-20
K993837 — AVL OPTI CRITICAL CARE ANALYZER1999-12-16
K990092 — AVL OMNI MODULAR ANALYZER1999-01-29
K974784 — AVL OPTI CRITICAL CARE ANALYZER1998-02-24

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