CALCIUM AND PH ELECTROLYTE ANALYZER— 510(k) K895397

Name: FDA 510(k) clearance K895397
Creator: U.S. Food and Drug Administration
Published: 1989-12-12

Substantially Equivalent

Ionetics, Inc.

FDA 510(k) clearance K895397 for CALCIUM AND PH ELECTROLYTE ANALYZER, Substantially Equivalent on 1989-12-12. Applicant: Ionetics, Inc.. Device class: 2.

Clearance details

Applicant: Ionetics, Inc.
Product code: Code JFP
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 1989-09-01
Decision date: 1989-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, 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 Ionetics, Inc.

view all

K932179 — MODEL 400/450 ELECTROLYTE ANALYZER1993-11-17
K890792 — POTASSIUM AND SODIUM ELECTROLYTE ANALYZER1989-05-03
K863907 — MODIFIED SODIUM ELECTRODE1986-12-10
K851808 — ELECTROLYTE ANALYZER1985-06-25
K830130 — MINIATURE ION SELECTIVE ELECTRODES1983-03-07

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