Cleared Traditional

I-STAT LACTATE TEST

K982071 · I-Stat Corp. · Chemistry
Jun 1998
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K982071 is an FDA 510(k) clearance for the I-STAT LACTATE TEST, a Acid, Lactic, Enzymatic Method (Class I — General Controls, product code KHP), submitted by I-Stat Corp. (Princeton, US). The FDA issued a Cleared decision on June 29, 1998, 17 days after receiving the submission on June 12, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1450.

Submission Details

510(k) Number K982071 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1998
Decision Date June 29, 1998
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHP — Acid, Lactic, Enzymatic Method
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1450

Similar Devices — KHP Acid, Lactic, Enzymatic Method

All 26
PICCOLO LACTATE TEST SYSTEM
K130113 · Abaxis, Inc. · Mar 2013
RAPIDPOINT 500 BLOOD GAS ANALYER
K113216 · Siemens Healthcare Diagnostics · May 2012
NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
K112955 · Nova Biomedical Corporation · Jan 2012
I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
K112430 · Abbott Pont of Care, Inc. · Dec 2011
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
K100602 · Nova Biomedical Corp. · Aug 2011
EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
K093297 · Epocal, Inc. · Jun 2010