Atlas FDA

KHP

27 FDA 510(k) clearances · Product code

76 daysmedian time to decision
231 days90th percentile
27clearances measured

FDA profile

Official device name
Acid, Lactic, Enzymatic Method
Device class
Class I (low risk)
Regulation
21 CFR 862.1450
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2003: 2 · 2013: 12 · 2014: 19 · 2015: 12 · 2016: 41 · 2018: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PICCOLO LACTATE TEST SYSTEM (K130113)Abaxis, Inc.2013-03-11
RAPIDPOINT 500 BLOOD GAS ANALYER (K113216)Siemens Healthcare Diagnostics2012-05-03
NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM (K112955)Nova Biomedical Corporation2012-01-05
I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE (K112430)Abbott Pont of Care, Inc.2011-12-20
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS (K100602)Nova Biomedical Corp.2011-08-17
EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE (K093297)Epocal, Inc.2010-06-09
IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE (K013938)Diametrics Medical, Inc.2002-01-28
I-STAT SYSTEM (K011478)I-Stat Corp.2001-07-02
LACTATE PRO SYSTEM (K980908)Kdk Corp.1998-09-11
I-STAT LACTATE TEST (K982071)I-Stat Corp.1998-06-29
LACTEST I (K971944)Jwt, Inc.1997-12-17
ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR (K951331)Boehringer Mannheim Corp.1995-08-11
STAT PROFILE PLUS 9 ANALYZER (K936066)Nova Biomedical Corp.1995-03-09
BECKMAN SYNCHRON LACTATE REAGENT (K934271)Beckman-Diagnostic Systems Group1993-11-09
DIMENSION(R) LACTIC ACID METHOD (K914508)E.I. Dupont DE Nemours & Co., Inc.1991-11-27
KODAK EKTACHEM DT SLIDES (LAC) (K913197)Eastman Kodak Company1991-08-26
URINE COLLECTION KIT/DEVICE (K913330)Medical Implements, Inc.1991-08-26
SYNCHRON LACTATE REAGENT (K910534)Beckman Instruments, Inc.1991-04-08
YSI MODEL 1500 SPORT L-LACTATE ANALYZER (K901131)Yellow Springs Instrument Co., Inc.1990-08-27
SIGMA PROCEDURE NO. 735 (K897147)Sigma Diagnostics, Inc.1990-04-03
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC) (K884189)Eastman Kodak Company1989-01-11
EASY-TEST LACTIC ACID (LA) (K880787)Diagnostic Systems1988-03-15
TDX REA LACTIC ACID (K861741)Abbott Laboratories1986-07-07
YSI MODEL 2372 TOTAL BLOOD LACTATE KIT (K852261)Yellow Springs Instrument Co., Inc.1985-08-15
LACTATE REAGENT (K840778)American Dade1984-04-13
DUPONT ACALACTIC ACID (LA) TEST (K802064)E.I. Dupont DE Nemours & Co., Inc.1980-09-26
ROCHE LACTATE ANALYZER 640 (K790421)Roche Medical Electronics, Inc.1979-05-15

Track KHP automatically

Every clearance here is in the API, with alerts when new ones post.