KHP · Class I · 21 CFR 862.1450

FDA Product Code KHP: Acid, Lactic, Enzymatic Method

Leading manufacturers include Eastman Kodak Company, Nova Biomedical Corp. and E.I. Dupont DE Nemours & 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 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 Aug 17, 2011
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
K100602
Nova Biomedical Corp.
Chemistry · 532d
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 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 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