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)
Top companies in KHP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2025 | Ortho-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 |
KHP | K955286 |
| Sep 12, 2025 | Ortho-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 |
KHP | K955286 |
| Feb 18, 2020 | Abbott 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 |
KHP | None listed |
| Apr 13, 2019 | Roche 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 |
KHP | K964457 |
| Nov 9, 2016 | Abbott Laboratories ARCHITECT Lactic Acid Part # 09D891T21
The Lactic Acid assay is used for the quantitation of lactic acid in human plasma. Terminated |
KHP | None listed |
| Aug 19, 2016 | Siemens 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 |
KHP | K113216 |
| Aug 11, 2016 | Ortho-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 |
KHP | K955286 |
| Apr 13, 2016 | Beckman 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 |
KHP | None listed |
| Feb 2, 2016 | Horiba 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 |
KHP | None listed |
| Sep 24, 2015 | Siemens 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 |
KHP | K113216 |
| Sep 24, 2015 | Siemens 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 |
KHP | K113216 |
| Sep 24, 2015 | Siemens 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 |
KHP | K113216 |
| Sep 24, 2015 | Siemens 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 |
KHP | K113216 |
| Aug 28, 2015 | Siemens 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 |
KHP | K002738 K020616 +2 |
| Jan 28, 2015 | Beckman Coulter Inc. Beckman Coulter, Lactate Assay, Catalog No. OSR6X93 Terminated |
KHP | None listed |
| Jul 18, 2014 | Siemens 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 |
KHP | K113216 |
| Sep 30, 2013 | Radiometer America Inc Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood. Terminated |
KHP | K002290 K043218 |
| Jun 27, 2013 | Beckman 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 |
KHP | None listed |
| May 24, 2013 | Beckman 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 |
KHP | None listed |
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