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Panels › Clinical Chemistry › Product code KHP · Class 1

Acid, Lactic, Enzymatic Method

Regulation 862.1450

0510(k)s in 12 months (27 all time)
0recalls in 12 months (19 all time)
12recalls that name a 510(k)
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Top companies in KHP

DateFirm and productCodeLinked 510(k)
Sep 12, 2025Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
Open, Classified
KHPK955286
Sep 12, 2025Ortho-Clinical Diagnostics, Inc.
Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
Open, Classified
KHPK955286
Feb 18, 2020Abbott Point Of Care Inc.
i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative measurement of lactate, pH, pCO2, and pO2 in venous
Terminated
KHPNone listed
Apr 13, 2019Roche Diagnostics Corporation
Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for t
Terminated
KHPK964457
Nov 9, 2016Abbott Laboratories
ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
Terminated
KHPNone listed
Aug 19, 2016Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This s
Terminated
KHPK113216
Aug 11, 2016Ortho-Clinical Diagnostics
VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier Nos. 10758750004911 and 10758750004454, R
Terminated
KHPK955286
Apr 13, 2016Beckman Coulter Inc.
Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Co
Terminated
KHPNone listed
Feb 2, 2016Horiba Instruments Inc
ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the
Terminated
KHPNone listed
Sep 24, 2015Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory envir
Terminated
KHPK113216
Sep 24, 2015Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory envir
Terminated
KHPK113216
Sep 24, 2015Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory envir
Terminated
KHPK113216
Sep 24, 2015Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory envir
Terminated
KHPK113216
Aug 28, 2015Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin de
Terminated
KHPK002738
K020616 +2
Jan 28, 2015Beckman Coulter Inc.
Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
Terminated
KHPNone listed
Jul 18, 2014Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Numbe
Terminated
KHPK113216
Sep 30, 2013Radiometer America Inc
Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
Terminated
KHPK002290
K043218
Jun 27, 2013Beckman Coulter Inc.
SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibra
Terminated
KHPNone listed
May 24, 2013Beckman Coulter Inc.
Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600
Terminated
KHPNone listed

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