CLINAK(TM) ISE SUBSYSTEM— 510(k) K910554

Name: FDA 510(k) clearance K910554
Creator: U.S. Food and Drug Administration
Published: 1991-03-06

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K910554 for CLINAK(TM) ISE SUBSYSTEM, Substantially Equivalent on 1991-03-06. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code JGS
Device class: Class 2
Regulation: 21 CFR 862.1665
Advisory panel: Clinical Chemistry
Date received: 1991-01-31
Decision date: 1991-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JGS

view all

K252475 — ABL90 FLEX PLUS System2026-05-01
K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
K222438 — A-LYTE® Integrated Multisensor (IMT Na K Cl)2023-07-25
K220977 — ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer2023-07-20
K213486 — GLP systems Track2022-03-10

More clearances from Baxter Healthcare Corp

view all

Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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