Cleared Traditional

PICCOLO LACTATE TEST SYSTEM

K130113 · Abaxis, Inc. · Chemistry
Mar 2013
Decision
54d
Days
Class 1
Risk

About This 510(k) Submission

K130113 is an FDA 510(k) clearance for the PICCOLO LACTATE TEST SYSTEM, a Acid, Lactic, Enzymatic Method (Class I — General Controls, product code KHP), submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on March 11, 2013, 54 days after receiving the submission on January 16, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1450.

Submission Details

510(k) Number K130113 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2013
Decision Date March 11, 2013
Days to Decision 54 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
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
IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
K013938 · Diametrics Medical, Inc. · Jan 2002