Cleared Traditional

AVL 9181 ELECTROLYTE ANALYZER

K972673 · Avl Scientific Corp. · Chemistry
Aug 1997
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K972673 is an FDA 510(k) clearance for the AVL 9181 ELECTROLYTE ANALYZER, a Electrode, Ion Specific, Calcium (Class II — Special Controls, product code JFP), submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on August 20, 1997, 35 days after receiving the submission on July 16, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K972673 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1997
Decision Date August 20, 1997
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFP — Electrode, Ion Specific, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

Similar Devices — JFP Electrode, Ion Specific, Calcium

All 28
i-STAT CG8+ cartridge with the i-STAT 1 System
K230300 · Abbott Point of Care, Inc. · Oct 2023
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191360 · Abbott Point of Care, Inc. · Feb 2020
Stat Profile Prime ES Comp Plus Analyzer System
K191626 · Nova Biomedical Corporation · Aug 2019
EasyLyte Na/K/Cl/Ca Analyzer
K152327 · Medica Corporation · Dec 2016
AVL OPTI CRITICAL CARE ANALYZER
K984299 · Avl Scientific Corp. · Dec 1998
EASYLYTE CALCIUM/CHLORIDE ANALYZER
K963694 · Medica Corp. · Nov 1996