FDA Product Code
FDA Product Code KHP — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1450
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K130113 | PICCOLO LACTATE TEST SYSTEM | Abaxis, Inc. | 2013-03-11 | Traditional | PDF ↗ |
| K113216 | RAPIDPOINT 500 BLOOD GAS ANALYER | Siemens Healthcare Diagnostics | 2012-05-03 | Traditional | PDF ↗ |
| K112955 | NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM | Nova Biomedical Corporation | 2012-01-05 | Traditional | PDF ↗ |
| K112430 | I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE | Abbott Pont of Care, Inc. | 2011-12-20 | Traditional | PDF ↗ |
| K100602 | NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS | Nova Biomedical Corp. | 2011-08-17 | Traditional | PDF ↗ |
| K093297 | EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE | Epocal, Inc. | 2010-06-09 | Traditional | PDF ↗ |
| K013938 | IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE | Diametrics Medical, Inc. | 2002-01-28 | Traditional | PDF ↗ |
| K011478 | I-STAT SYSTEM | I-Stat Corp. | 2001-07-02 | Traditional | PDF ↗ |
| K980908 | LACTATE PRO SYSTEM | Kdk Corp. | 1998-09-11 | Traditional | PDF ↗ |
| K982071 | I-STAT LACTATE TEST | I-Stat Corp. | 1998-06-29 | Traditional | PDF ↗ |
| K971944 | LACTEST I | Jwt, Inc. | 1997-12-17 | Traditional | PDF ↗ |
| K951331 | ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR | Boehringer Mannheim Corp. | 1995-08-11 | Traditional | PDF ↗ |
| K936066 | STAT PROFILE PLUS 9 ANALYZER | Nova Biomedical Corp. | 1995-03-09 | Traditional | PDF ↗ |
| K934271 | BECKMAN SYNCHRON LACTATE REAGENT | Beckman-Diagnostic Systems Group | 1993-11-09 | Traditional | PDF ↗ |
| K914508 | DIMENSION(R) LACTIC ACID METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1991-11-27 | Traditional | PDF ↗ |
| K913197 | KODAK EKTACHEM DT SLIDES (LAC) | Eastman Kodak Company | 1991-08-26 | Traditional | PDF ↗ |
| K913330 | URINE COLLECTION KIT/DEVICE | Medical Implements, Inc. | 1991-08-26 | Traditional | PDF ↗ |
| K910534 | SYNCHRON LACTATE REAGENT | Beckman Instruments, Inc. | 1991-04-08 | Traditional | PDF ↗ |
| K901131 | YSI MODEL 1500 SPORT L-LACTATE ANALYZER | Yellow Springs Instrument Co., Inc. | 1990-08-27 | Traditional | PDF ↗ |
| K897147 | SIGMA PROCEDURE NO. 735 | Sigma Diagnostics, Inc. | 1990-04-03 | Traditional | PDF ↗ |
| K884189 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC) | Eastman Kodak Company | 1989-01-11 | Traditional | PDF ↗ |
| K880787 | EASY-TEST LACTIC ACID (LA) | Diagnostic Systems | 1988-03-15 | Traditional | PDF ↗ |
| K861741 | TDX REA LACTIC ACID | Abbott Laboratories | 1986-07-07 | Traditional | PDF ↗ |
| K852261 | YSI MODEL 2372 TOTAL BLOOD LACTATE KIT | Yellow Springs Instrument Co., Inc. | 1985-08-15 | Traditional | PDF ↗ |
| K840778 | LACTATE REAGENT | American Dade | 1984-04-13 | Traditional | PDF ↗ |
| K802064 | DUPONT ACALACTIC ACID (LA) TEST | E.I. Dupont DE Nemours & Co., Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K790421 | ROCHE LACTATE ANALYZER 640 | Roche Medical Electronics, Inc. | 1979-05-15 | Traditional | PDF ↗ |
Product code KHP · Class I · Clinical Chemistry. Data: openFDA.