IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE— 510(k) K013938

Name: FDA 510(k) clearance K013938
Creator: U.S. Food and Drug Administration
Published: 2002-01-28

Substantially Equivalent

Diametrics Medical, Inc.

FDA 510(k) clearance K013938 for IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE, Substantially Equivalent on 2002-01-28. Applicant: Diametrics Medical, Inc.. Device class: 1.

Clearance details

Applicant: Diametrics Medical, Inc.
Product code: Code KHP
Device class: Class 1
Regulation: 21 CFR 862.1450
Advisory panel: Clinical Chemistry
Date received: 2001-11-28
Decision date: 2002-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseville, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHP

view all

K130113 — PICCOLO LACTATE TEST SYSTEM2013-03-11
K113216 — RAPIDPOINT 500 BLOOD GAS ANALYER2012-05-03
K112955 — NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM2012-01-05
K112430 — I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE2011-12-20
K100602 — NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS2011-08-17

More clearances from Diametrics Medical, Inc.

view all

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