IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE— 510(k) K980523

Name: FDA 510(k) clearance K980523
Creator: U.S. Food and Drug Administration
Published: 1998-03-19

Substantially Equivalent

Diametrics Medical, Inc.

FDA 510(k) clearance K980523 for IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE, Substantially Equivalent on 1998-03-19. Applicant: Diametrics Medical, Inc.. Device class: 2.

Clearance details

Applicant: Diametrics Medical, Inc.
Product code: Code CHL
Device class: Class 2
Regulation: 21 CFR 862.1120
Advisory panel: Clinical Chemistry
Date received: 1998-02-10
Decision date: 1998-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseville, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHL

view all

K252207 — ABL90 FLEX PLUS System, safeCLINITUBES2026-04-10
K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System2025-05-02
K240998 — ABL90 FLEX PLUS System2024-12-13
K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
K221900 — Stat Profile Prime Plus Analyzer System2023-09-29

More clearances from Diametrics Medical, Inc.

view all

K030035 — IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE2003-06-25
K013938 — IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE2002-01-28
K011586 — IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE2001-11-16
K981270 — IRMA BLOOD ANALYSIS SYSTEM1998-05-01
K974396 — IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE1997-12-18

Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

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.