KHP · Class I · 21 CFR 862.1450

FDA Product Code KHP: Acid, Lactic, Enzymatic Method

Leading manufacturers include Nova Biomedical Corp., E.I. Dupont DE Nemours & Co., Inc. and Yellow Springs Instrument Co., Inc..

27
Total
27
Cleared
121d
Avg days
1979
Since

FDA 510(k) Cleared Acid, Lactic, Enzymatic Method Devices (Product Code KHP)

27 devices
1–24 of 27
Cleared Mar 11, 2013
PICCOLO LACTATE TEST SYSTEM
K130113
Abaxis, Inc.
Chemistry · 54d
Cleared May 03, 2012
RAPIDPOINT 500 BLOOD GAS ANALYER
K113216
Siemens Healthcare Diagnostics
Chemistry · 184d
Cleared Jan 05, 2012
NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
K112955
Nova Biomedical Corporation
Chemistry · 93d
Cleared Dec 20, 2011
I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
K112430
Abbott Pont of Care, Inc.
Chemistry · 118d
Cleared Aug 17, 2011
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
K100602
Nova Biomedical Corp.
Chemistry · 532d
Cleared Sep 11, 1998
LACTATE PRO SYSTEM
K980908
Kdk Corp.
Chemistry · 185d
Cleared Jun 29, 1998
I-STAT LACTATE TEST
K982071
I-Stat Corp.
Chemistry · 17d
Cleared Dec 17, 1997
LACTEST I
K971944
Jwt, Inc.
Chemistry · 204d
Cleared Aug 11, 1995
ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR
K951331
Boehringer Mannheim Corp.
Chemistry · 140d
Cleared Mar 09, 1995
STAT PROFILE PLUS 9 ANALYZER
K936066
Nova Biomedical Corp.
Chemistry · 443d
Cleared Nov 27, 1991
DIMENSION(R) LACTIC ACID METHOD
K914508
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 49d
Cleared Aug 26, 1991
KODAK EKTACHEM DT SLIDES (LAC)
K913197
Eastman Kodak Company
Chemistry · 39d
Cleared Apr 08, 1991
SYNCHRON LACTATE REAGENT
K910534
Beckman Instruments, Inc.
Chemistry · 59d
Cleared Aug 27, 1990
YSI MODEL 1500 SPORT L-LACTATE ANALYZER
K901131
Yellow Springs Instrument Co., Inc.
Chemistry · 168d
Cleared Apr 03, 1990
SIGMA PROCEDURE NO. 735
K897147
Sigma Diagnostics, Inc.
Chemistry · 98d
Cleared Jan 11, 1989
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC)
K884189
Eastman Kodak Company
Chemistry · 98d
Cleared Jul 07, 1986
TDX REA LACTIC ACID
K861741
Abbott Laboratories
Chemistry · 62d
Cleared Aug 15, 1985
YSI MODEL 2372 TOTAL BLOOD LACTATE KIT
K852261
Yellow Springs Instrument Co., Inc.
Chemistry · 83d
Cleared Apr 13, 1984
LACTATE REAGENT
K840778
American Dade
Chemistry · 65d
Cleared Sep 26, 1980
DUPONT ACALACTIC ACID (LA) TEST
K802064
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 30d

About Product Code KHP - Regulatory Context