FDA Product Code
FDA Product Code CHL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1120
510(k) Clearances — 188 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps | 2026-04-10 | Traditional | PDF ↗ |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2025-05-02 | Traditional | PDF ↗ |
| K240998 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2024-12-13 | Traditional | PDF ↗ |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-10-27 | Traditional | PDF ↗ |
| K221900 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2023-09-29 | Traditional | PDF ↗ |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-09-15 | Traditional | PDF ↗ |
| K223608 | GEM Premier 7000 with IQM3 | Instrumentation Laboratory Company | 2023-08-10 | Traditional | PDF ↗ |
| K211559 | EasyStat 300 | Medica Corporation | 2023-01-27 | Traditional | PDF ↗ |
| K203790 | GEM Premier 5000 | Instrumentation Laboratory CO | 2021-08-20 | Special | PDF ↗ |
| K200986 | OPTI® B-Lac Cassette | Opti Medical Systems, Inc. | 2021-08-02 | Traditional | PDF ↗ |
| K200107 | epoc Blood Analysis System | Epocal, Inc. | 2020-06-05 | Special | PDF ↗ |
| K200492 | i-STAT CG4+ Cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-04-09 | Traditional | PDF ↗ |
| K192240 | RAPIDPoint 500e Blood Gas System | Siemens Healthcare Diagnostics, Inc. | 2020-03-27 | Special | PDF ↗ |
| K193246 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020-01-24 | Traditional | PDF ↗ |
| K173797 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018-07-17 | Traditional | PDF ↗ |
| K173403 | GEM Premier 5000 | Instrumentation Laboratory CO | 2017-12-29 | Traditional | PDF ↗ |
| K160412 | GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) | Instrumentation Laboratory CO | 2016-12-14 | Traditional | PDF ↗ |
| K160153 | ABL90 FLEX PLUS | Radiometer Medical Aps | 2016-11-04 | Special | PDF ↗ |
| K151978 | EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control | Edan Instruments, Inc. | 2016-07-15 | Traditional | PDF ↗ |
| K151982 | Stat Profile Prime ABG Analyzer System | Nova Biomedical Corporation | 2015-09-10 | Traditional | PDF ↗ |
| K151856 | ABL80 FLEX CO-OX with AQURE connectivity | Sendx Medical, Inc. | 2015-08-06 | Special | PDF ↗ |
| K142898 | ABL800 FLEX with AQURE connectivity | Radiometer Medical Aps | 2015-06-17 | Special | PDF ↗ |
| K141907 | STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A | Nova Biomedical Corporation | 2015-05-29 | Traditional | PDF ↗ |
| K142220 | Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) | Nova Biomedical Corporation | 2014-10-17 | Traditional | PDF ↗ |
| K131703 | NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM | Nova Biomedical Corporation | 2014-03-25 | Traditional | PDF ↗ |
| K133407 | GEM PREMIER 4000 | Instrumentation Laboratory CO | 2014-01-13 | Special | PDF ↗ |
| K131988 | ABL90 FLEX ANALYZER | Radiometer Medical Aps | 2013-09-17 | Traditional | PDF ↗ |
| K131126 | OPTI CCA-TS2 | Opti Medical Systems, Inc. | 2013-08-22 | Traditional | PDF ↗ |
| K130144 | ABL90 FLEX | Radiometer Medical Aps | 2013-07-31 | Special | PDF ↗ |
| K123748 | ABL90 FLEX | Radiometer Medical Aps | 2013-05-07 | Special | PDF ↗ |
| K122539 | MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM | Siemens Healthcare Diagnostics | 2013-04-19 | Traditional | PDF ↗ |
| K122729 | ABL90 FLEX | Radiometer Medical Aps | 2012-11-16 | Special | PDF ↗ |
| K122642 | ABL90 FLEX | Radiometer Medical Aps | 2012-10-26 | Special | PDF ↗ |
| K111188 | COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B | Roche Diagnostics | 2012-05-14 | Traditional | PDF ↗ |
| K120197 | ABL90 FLEX | Radiometer Medical Aps | 2012-03-19 | Special | PDF ↗ |
| K110648 | NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM | Nova Biomedical Corporation | 2011-08-29 | Special | PDF ↗ |
| K111897 | ABL90 | Radiometer Medical Aps | 2011-07-19 | Special | PDF ↗ |
| K110416 | ABL835 FLEX ANALYZER WITH PLEURAL PH | Radiometer Medical Aps | 2011-03-24 | Traditional | PDF ↗ |
| K093280 | OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 | Opti Medical Systems, Inc. | 2011-01-07 | Traditional | PDF ↗ |
| K100777 | ABL837 FLEX ANALYZER | Radiometer Medical Aps | 2010-12-10 | Abbreviated | PDF ↗ |
| K080370 | ABL 80 CO-OX SYSTEM | Sendx Medical, Inc. | 2008-07-31 | Traditional | PDF ↗ |
| K063376 | EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER | Medica Corp. | 2007-06-25 | Traditional | PDF ↗ |
| K061974 | GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT | Instrumentation Laboratory CO | 2006-09-15 | Traditional | PDF ↗ |
| K051804 | ABL80 FLEX ANALYZER | Sendx Medical, Inc. | 2005-11-01 | Traditional | PDF ↗ |
| K043218 | ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX | Radiometer Medical Aps | 2005-05-10 | Traditional | PDF ↗ |
| K050423 | OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE) | Roche Diagnostics | 2005-04-22 | Traditional | PDF ↗ |
| K041874 | ABL800 FLEX | Radiometer Medical Aps | 2004-10-08 | Traditional | PDF ↗ |
| K031560 | BAYER RAPIDLAB 1200 SYSTEM | Bayer Healthcare, LLC | 2003-12-17 | Traditional | PDF ↗ |
| K023567 | STAT PROFILE PHOX PLUS L ANALYZER | Nova Biomedical Corp. | 2002-12-20 | Abbreviated | PDF ↗ |
| K022746 | STAT PROFILE CRITICAL CARE XPRESS ANALYZER | Nova Biomedical Corp. | 2002-11-22 | Traditional | PDF ↗ |
| K021713 | STAT PROFILE PHOX PLUS C ANALYZER | Nova Biomedical Corp. | 2002-07-25 | Traditional | PDF ↗ |
| K021515 | EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER | Medica Corp. | 2002-07-16 | Traditional | PDF ↗ |
| K020297 | STAT PROFILE CRITICAL CARE XPRESS ANALYZER | Nova Biomedical Corp. | 2002-06-10 | Traditional | PDF ↗ |
| K014295 | STAT PROFILE PHOX ANALYZER | Nova Biomedical Corp. | 2002-02-28 | Traditional | PDF ↗ |
| K013729 | STAT PROFILE PHOX BASIC ANALYZER | Nova Biomedical Corp. | 2002-01-15 | Traditional | PDF ↗ |
| K012478 | MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER | I-Stat Corp. | 2001-08-20 | Special | PDF ↗ |
| K012058 | STAT PROFILE PHOX PLUS L ANALYZER | Nova Biomedical Corp. | 2001-08-20 | Traditional | PDF ↗ |
| K002738 | BAYER RAPIDPOINT 400 SYSTEM | Bayer Corp. | 2000-12-19 | Traditional | PDF ↗ |
| K002613 | MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER | Nova Biomedical Corp. | 2000-10-19 | Traditional | PDF ↗ |
| K002290 | ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) | Radiometer Medical A/S | 2000-09-13 | Traditional | PDF ↗ |
| K000103 | AVL OPTI R ANALYZER | Avl Scientific Corp. | 2000-03-20 | Traditional | PDF ↗ |
| K994346 | ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM | Sendx Medical, Inc. | 2000-02-01 | Traditional | PDF ↗ |
| K993789 | CLINICAL BLOOD GAS MIXTURE | General Air Service and Supply | 2000-01-10 | Traditional | PDF ↗ |
| K992859 | ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE | Radiometer America, Inc. | 2000-01-10 | Special | PDF ↗ |
| K991417 | ABL 735 ANALYZER | Radiometer America, Inc. | 1999-11-24 | Traditional | PDF ↗ |
| K992834 | GEM PREMIER 3000 | Instrumentation Laboratory CO | 1999-11-24 | Traditional | PDF ↗ |
| K990092 | AVL OMNI MODULAR ANALYZER | Avl Scientific Corp. | 1999-01-29 | Traditional | PDF ↗ |
| K982928 | NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM | Radiometer America, Inc. | 1999-01-06 | Traditional | PDF ↗ |
| K984384 | 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 | Thermo Bioanalysis Corp. | 1998-12-23 | Traditional | PDF ↗ |
| K982277 | MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991) | Nova Biomedical Corp. | 1998-07-22 | Traditional | PDF ↗ |
| K980991 | NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER | Nova Biomedical Corp. | 1998-04-15 | Traditional | PDF ↗ |
| K980523 | IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE | Diametrics Medical, Inc. | 1998-03-19 | Traditional | PDF ↗ |
| K980130 | ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM | Radiometer America, Inc. | 1998-02-09 | Traditional | PDF ↗ |
| K974526 | EASYBLOOD GAS ANALYZER | Medica Corp. | 1998-02-05 | Traditional | PDF ↗ |
| K974396 | IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE | Diametrics Medical, Inc. | 1997-12-18 | Traditional | PDF ↗ |
| K973367 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | Radiometer America, Inc. | 1997-10-06 | Traditional | PDF ↗ |
| K970710 | STAT PROFILE ULTRA M ANALYZER | Nova Biomedical Corp. | 1997-05-09 | Traditional | PDF ↗ |
| K963964 | AVL COMPACT 3 PH/BLOOD GAS ANALYZER | Avl Scientific Corp. | 1996-11-29 | Traditional | PDF ↗ |
| K963800 | IL SYNTHESIS | Instrumentation Laboratory CO | 1996-11-13 | Traditional | PDF ↗ |
| K961335 | GEM PREMIER PLUS MODEL 5500 | Mallinckrodt Sensor Systems, Inc. | 1996-06-28 | Traditional | PDF ↗ |
| K961657 | CIBA CORNING 400 SYSTEM | Ciba Corning Diagnostics Corp. | 1996-06-25 | Traditional | PDF ↗ |
| K962021 | CIBA CORNING 348 SYSTEM | Ciba Corning Diagnostics Corp. | 1996-06-24 | Traditional | PDF ↗ |
| K961161 | AVL OPTI 1 PH/BLOOD GAS ANALYZER | Avl Scientific Corp. | 1996-04-26 | Traditional | PDF ↗ |
| K955793 | IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM | Instrumentation Laboratory CO | 1996-02-14 | Traditional | PDF ↗ |
| K954482 | SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM | Cirrus Medical,Inc. | 1995-12-04 | Traditional | PDF ↗ |
| K954711 | STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION) | Nova Biomedical Corp. | 1995-11-30 | Traditional | PDF ↗ |
| K953935 | MED-TECH CLINICAL BLOOD GAS | Medical Technical Gases Inc.. | 1995-11-20 | Traditional | PDF ↗ |
| K954612 | ABL SYSTEM 625, 615, 605 | Radiometer America, Inc. | 1995-11-09 | Traditional | PDF ↗ |
| K943882 | ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM | Radiometer America, Inc. | 1995-03-10 | Traditional | PDF ↗ |
| K936203 | STAT PROFILE PLUS 10 ANALYZER | Nova Biomedical Corp. | 1995-03-09 | Traditional | PDF ↗ |
| K946206 | CIBA CORNING 8-- SERIES CO-OXIMETER | Ciba Corning Diagnostics Corp. | 1995-01-30 | Traditional | PDF ↗ |
| K945240 | IRMA BLOOD ANALYSIS SYSTEM | Diametrics Medical, Inc. | 1995-01-05 | Traditional | PDF ↗ |
| K943643 | STAT PROFILE ULTRA 11 ANALYZER | Nova Biomedical Corp. | 1994-12-29 | Traditional | PDF ↗ |
| K944089 | AVL OPTI PH/BLOOD GAS ANALYZER | Avl Scientific Corp. | 1994-10-20 | Traditional | PDF ↗ |
| K943570 | AVL COMPACT 1 PH/BLOOD GAS ANALYZER | Avl Scientific Corp. | 1994-08-24 | Traditional | PDF ↗ |
| K942616 | AVL COMPACT 2 PH/BLOOD GAS ANALYZER | Avl Scientific Corp. | 1994-07-28 | Traditional | PDF ↗ |
| K935121 | ABL SYSTEM 620 | Radiometer America, Inc. | 1994-05-27 | Traditional | PDF ↗ |
| K935655 | ABL5 BLOOD GAS SYSTEM | Radiometer America, Inc. | 1994-05-27 | Traditional | PDF ↗ |
| K940918 | I-STAT 200 PORTABLE CLINICAL ANALYZER | I-Stat Corp. | 1994-05-10 | Traditional | PDF ↗ |
| K935069 | IL1430 BGELECTROLYTE ANALYZER | Instrumentation Laboratory CO | 1994-03-28 | Traditional | PDF ↗ |
Product code CHL · Class II · Clinical Chemistry. Data: openFDA.