Product code KHP
- Device name
- Acid, Lactic, Enzymatic Method
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1450
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130113 | PICCOLO LACTATE TEST SYSTEM | Abaxis, Inc. | 2013-03-11 |
| K113216 | RAPIDPOINT 500 BLOOD GAS ANALYER | Siemens Healthcare Diagnostics | 2012-05-03 |
| K112955 | NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM | Nova Biomedical Corporation | 2012-01-05 |
| K112430 | I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE | Abbott Pont of Care, Inc. | 2011-12-20 |
| K100602 | NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS | Nova Biomedical Corp. | 2011-08-17 |
| K093297 | EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE | Epocal, Inc. | 2010-06-09 |
| K013938 | IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE | Diametrics Medical, Inc. | 2002-01-28 |
| K011478 | I-STAT SYSTEM | I-Stat Corp. | 2001-07-02 |
| K980908 | LACTATE PRO SYSTEM | Kdk Corp. | 1998-09-11 |
| K982071 | I-STAT LACTATE TEST | I-Stat Corp. | 1998-06-29 |
| K971944 | LACTEST I | Jwt, Inc. | 1997-12-17 |
| K951331 | ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR | Boehringer Mannheim Corp. | 1995-08-11 |
| K936066 | STAT PROFILE PLUS 9 ANALYZER | Nova Biomedical Corp. | 1995-03-09 |
| K934271 | BECKMAN SYNCHRON LACTATE REAGENT | Beckman-Diagnostic Systems Group | 1993-11-09 |
| K914508 | DIMENSION(R) LACTIC ACID METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1991-11-27 |
| K913197 | KODAK EKTACHEM DT SLIDES (LAC) | Eastman Kodak Company | 1991-08-26 |
| K913330 | URINE COLLECTION KIT/DEVICE | Medical Implements, Inc. | 1991-08-26 |
| K910534 | SYNCHRON LACTATE REAGENT | Beckman Instruments, Inc. | 1991-04-08 |
| K901131 | YSI MODEL 1500 SPORT L-LACTATE ANALYZER | Yellow Springs Instrument Co., Inc. | 1990-08-27 |
| K897147 | SIGMA PROCEDURE NO. 735 | Sigma Diagnostics, Inc. | 1990-04-03 |
| K884189 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC) | Eastman Kodak Company | 1989-01-11 |
| K880787 | EASY-TEST LACTIC ACID (LA) | Diagnostic Systems | 1988-03-15 |
| K861741 | TDX REA LACTIC ACID | Abbott Laboratories | 1986-07-07 |
| K852261 | YSI MODEL 2372 TOTAL BLOOD LACTATE KIT | Yellow Springs Instrument Co., Inc. | 1985-08-15 |
| K840778 | LACTATE REAGENT | American Dade | 1984-04-13 |
| K802064 | DUPONT ACALACTIC ACID (LA) TEST | E.I. Dupont DE Nemours & Co., Inc. | 1980-09-26 |
| K790421 | ROCHE LACTATE ANALYZER 640 | Roche Medical Electronics, Inc. | 1979-05-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10385480408131 | Lactate Plus | NOVA BIOMEDICAL CORPORATION | 2022-12-08 |
| 10054749005502 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-10-05 |
| 08426950807605 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 600 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807599 | GEM Premier 5000 PAK BG/ISE/GL/COOX 600 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807827 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 450 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807810 | GEM Premier 5000 PAK BG/ISE/GL/COOX 450 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807766 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 300 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807704 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 150 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807698 | GEM Premier 5000 PAK BG/ISE/GL/COOX 150 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807643 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807636 | GEM Premier 5000 PAK BG/ISE/GL/COOX 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807759 | GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 00385480118026 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-22 |
| 00385480362597 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480359429 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480347174 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480340816 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480336239 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480329651 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480248198 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480243278 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480230230 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480225076 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480214971 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 10385480474860 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480364553 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480364577 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480364539 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480134095 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480115339 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |