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 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K936081 | I-STAT TESTS FOR ACID-BASE PARAMETERS | I-Stat Corp. | 1994-02-24 | Traditional | PDF ↗ |
| K935830 | CIBA CORNING 248 PH/BLOOD GAS ANALYZER | Ciba Corning Diagnostics Corp. | 1994-02-03 | Traditional | PDF ↗ |
| K934907 | 860 MEASURMENT SYSTEM | Ciba Corning Diagnostics Corp. | 1994-01-03 | Traditional | PDF ↗ |
| K932642 | AVL 9110PH ANALYZER | Avl Scientific Corp. | 1993-10-14 | Traditional | PDF ↗ |
| K924497 | STAT PROFILE 9 ANALYZER | Nova Biomedical Corp. | 1993-02-23 | Traditional | PDF ↗ |
| K924758 | DMI BLOOD GAS ANALYZER/CARTRIDGE | Diamond Medical, Inc. | 1992-12-03 | Traditional | PDF ↗ |
| K922631 | STATPAL II BLOOD GAS ANALYSIS SYSTEM | Ppg Industries, Inc. | 1992-11-10 | Traditional | PDF ↗ |
| K922922 | ABL50 BLOOD GAS SYSTEM | Radiometer America, Inc. | 1992-08-28 | Traditional | PDF ↗ |
| K914166 | ABL505 BLOOD GAS & ELECTROLYTE SYSTEM | Radiometer America, Inc. | 1992-01-28 | Traditional | PDF ↗ |
| K915087 | DMI BLOD GAS ANALYZER/CARTRIDGE | Diamond Medical, Inc. | 1992-01-08 | Traditional | PDF ↗ |
| K914560 | STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL | Ppg Industries, Inc. | 1991-11-29 | Traditional | PDF ↗ |
| K913927 | IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST | Instrumentation Laboratory CO | 1991-10-11 | Traditional | PDF ↗ |
| K903965 | STATPAL BLOOD GAS MONITORING SYSTEM | Ppg Industries, Inc. | 1990-12-26 | Traditional | PDF ↗ |
| K904513 | ABL510 BLOOD GAS SYSTEM | Radiometer America, Inc. | 1990-12-13 | Traditional | PDF ↗ |
| K904188 | CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZER | Ciba Corning Diagnostics Corp. | 1990-09-27 | Traditional | PDF ↗ |
| K902267 | BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS | Phoenix Diagnostics, Inc. | 1990-06-12 | Traditional | PDF ↗ |
| K895317 | AVL MODEL 995HB PH/BLOOD GAS ANALYZER | Avl Scientific Corp. | 1990-02-01 | Traditional | PDF ↗ |
| K895181 | ABL500 BLOOD GAS SYSTEM | Radiometer America, Inc. | 1989-10-06 | Traditional | PDF ↗ |
| K890827 | IL1400, BGELECTROLYTE ANALYZER | Instrumentation Laboratory CO | 1989-06-20 | Traditional | PDF ↗ |
| K891578 | AVL MODEL 987 ELECTROLYTE ANALYZER | Avl Scientific Corp. | 1989-05-22 | Traditional | PDF ↗ |
| K884267 | ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS | Alko Diagnostic Corp. | 1989-05-04 | Traditional | PDF ↗ |
| K884143 | NOVA STAT PROFILE 7 ANALYZER QUALITY CONTROL MATER | Nova Biomedical Corp. | 1988-12-02 | Traditional | PDF ↗ |
| K882941 | BLOOD GAS MIXTURE | Swisco, Inc. | 1988-09-09 | Traditional | PDF ↗ |
| K882209 | MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES | Linde Div. Union Carbide Corp. | 1988-08-02 | Traditional | PDF ↗ |
| K881188 | BLOOD PH CAPILLARY TUBES, HEPARIN | Helps Products, Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K873577 | GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK | Diamond Sensor Systems | 1988-04-28 | Traditional | PDF ↗ |
| K871397 | ANALYZER: NOVA STAT PROFILE 3 ANALYZER | Nova Biomedical Corp. | 1987-06-03 | Traditional | PDF ↗ |
| K865036 | CIBA CORNING MODEL 278 PH/BLOOD GAS SYSTEM | Ciba Corning Diagnostics Corp. | 1987-03-06 | Traditional | PDF ↗ |
| K864445 | STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL | Nova Biomedical Corp. | 1987-02-04 | Traditional | PDF ↗ |
| K863880 | BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD. | D.R.G. Scientific Industries | 1986-11-24 | Traditional | PDF ↗ |
| K860057 | ABL330 ACID BASE LABORATORY | Radiometer America, Inc. | 1986-03-05 | Traditional | PDF ↗ |
| K853840 | LIFE WATCH RESPIRATORY MONITOR | The Perkin-Elmer Corp. | 1985-12-09 | Traditional | PDF ↗ |
| K854608 | ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT. | Nova Biomedical Corp. | 1985-12-05 | Traditional | PDF ↗ |
| K853405 | ELECTROLYTE ANALYZER SERA-252 | Horiba Instruments, Inc. | 1985-12-04 | Traditional | PDF ↗ |
| K852790 | ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT | Nova Biomedical Corp. | 1985-11-12 | Traditional | PDF ↗ |
| K852676 | IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS | Allied Instrumentation Laboratory | 1985-07-22 | Traditional | PDF ↗ |
| K850360 | ESCHWEILER SYSTEM 2000 - GLOOD GAS ANALYZERS | Text Tech Corp. | 1985-04-17 | Traditional | PDF ↗ |
| K844781 | MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB | Shaban Mfg. Co. | 1985-02-01 | Traditional | PDF ↗ |
| K844295 | ABL300 ACID BASE LABORATORY | Radiometer America, Inc. | 1984-12-10 | Traditional | PDF ↗ |
| K842519 | BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302 | Rna Medical Corp. | 1984-08-17 | Traditional | PDF ↗ |
| K841609 | COMPONENTS FOR PARTIAL PRESSURE ELEE | Shaban Mfg. Co. | 1984-05-25 | Traditional | PDF ↗ |
| K840843 | POTASSIUM CHLORIDE TABLETS | Bionostics, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K840468 | PARTIAL PRESS. ELECTRODE MEASUREMENT | Shaban Mfg. Co. | 1984-03-30 | Traditional | PDF ↗ |
| K840300 | FLUSH SOLUTION CONCENTRATE-BLOOD GAS | Bionostics, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K834601 | AVL MODEL 945 BLOOD GAS SYSTEM | Avl Scientific Corp. | 1984-03-09 | Traditional | PDF ↗ |
| K833536 | PARTIAL PRESSURE ELECTRODE MEASUREMENT | Shaban Mfg. Co. | 1983-12-29 | Traditional | PDF ↗ |
| K833534 | PARTIAL PRESSURE ELECTRODE MEASUREMENT | Shaban Mfg. Co. | 1983-12-29 | Traditional | PDF ↗ |
| K832981 | ELECTRODES FOR BLOOD GAS ANALYZERS | Analytical Products, Inc. | 1983-10-28 | Traditional | PDF ↗ |
| K832779 | REFEREE BLOOD GAS ANALYZER-ELECTRODES | Analytical Products, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K831379 | MODEL 947 VIDEO BLOOD GAS SYS | Avl Scientific Corp. | 1983-07-28 | Traditional | PDF ↗ |
| K831025 | ELECTROLYLE CARBON DIOXIDE ELECTRODES | Fisher Scientific Co., LLC | 1983-06-16 | Traditional | PDF ↗ |
| K831021 | CALIBRATING SOLUTION FOR ABL-1 & 2 | Fisher Scientific Co., LLC | 1983-06-16 | Traditional | PDF ↗ |
| K831019 | PH 6.838 REF. BUFFER | Fisher Scientific Co., LLC | 1983-06-16 | Traditional | PDF ↗ |
| K831024 | ELECTROLYTE PO2 FOR OXYGEN ELECTRODES | Fisher Scientific Co., LLC | 1983-06-16 | Traditional | PDF ↗ |
| K831018 | CALIBRATING SOLUTION FOR ABL-1 & 2 | Fisher Scientific Co., LLC | 1983-06-16 | Traditional | PDF ↗ |
| K831023 | REFERENCE BUFFER PH 7.382 | Fisher Scientific Co., LLC | 1983-06-15 | Traditional | PDF ↗ |
| K831012 | DIAGNOSTICS PCO2 ELECTROLYTE W/CARBON | Fisher Scientific Co., LLC | 1983-06-08 | Traditional | PDF ↗ |
| K831013 | DIAGNOSTICS PO 2 ELECTROLYTE | Fisher Scientific Co., LLC | 1983-06-08 | Traditional | PDF ↗ |
| K831015 | DIAGNOSTICS PH ELECTRODE CLEANING SOLUT | Fisher Scientific Co., LLC | 1983-05-25 | Traditional | PDF ↗ |
| K831020 | FLUSH SOLUTION CONCENTRATE | Fisher Scientific Co., LLC | 1983-05-09 | Traditional | PDF ↗ |
| K831017 | BUFFER PACK FOR ABL-1 & ABL-2 | Fisher Scientific Co., LLC | 1983-05-09 | Traditional | PDF ↗ |
| K831016 | BATH CLEAR | Fisher Scientific Co., LLC | 1983-05-05 | Traditional | PDF ↗ |
| K831010 | DIAGNOSTICS PO2 ELECTRODE CLEANER | Fisher Scientific Co., LLC | 1983-05-05 | Traditional | PDF ↗ |
| K823750 | CLEANING AGENT | Shaban Mfg. Co. | 1983-01-14 | Traditional | PDF ↗ |
| K823570 | CORNING 170 PH/BLOOD GAS ANALYZER | Corning Medical & Scientific | 1982-12-28 | Traditional | PDF ↗ |
| K821483 | IL 1302 PH BLOOD GAS ANALYZER | Instrumentation Laboratory CO | 1982-06-10 | Traditional | PDF ↗ |
| K820744 | IL MODEL 1301, PH BLOOD GAS SYSTEM | Instrumentation Laboratory CO | 1982-04-15 | Traditional | PDF ↗ |
| K820597 | 158 BLOOD GAS ANALYZER | Corning Medical & Scientific | 1982-03-26 | Traditional | PDF ↗ |
| K813517 | BLOOD GAS ANALYSIS, STANDARDS CONTROLS | United Diagnostics, Inc. | 1981-12-31 | Traditional | PDF ↗ |
| K812090 | LORENZ BLOOD GAS ANALYZER | Lorenz Instruments | 1981-11-10 | Traditional | PDF ↗ |
| K812623 | CLEANING SOLUTION FOR RADIOMETER OSM2 | Fisher Scientific Co., LLC | 1981-11-02 | Traditional | PDF ↗ |
| K812552 | COROMETRICS MEDICAL SYST. 220 PH ANALY. | Transidyne General Corp. | 1981-09-23 | Traditional | PDF ↗ |
| K810724 | CORNING 178 BLOOD GAS ANALYZER | Corning Medical & Scientific | 1981-03-31 | Traditional | PDF ↗ |
| K810308 | ARTERIAL MICROCOLLECTION SET | American Dade | 1981-02-19 | Traditional | PDF ↗ |
| K800757 | IL MODEL 1303 PH/BLOOD GAS ANALYZER | Instrumentation Laboratory CO | 1980-04-21 | Traditional | PDF ↗ |
| K800271 | COROMETRICS MEDICAL SYSTEMS 220 PH SYS. | Transidyne General Corp. | 1980-02-26 | Traditional | PDF ↗ |
| K800224 | RADIOMETER ACID BASE LABORATORY-ABL-3 | The London Co. | 1980-02-22 | Traditional | PDF ↗ |
| K792230 | AVL MODEL 940 AUTOMATIC PH/BLOOD GAS | Gauntlet Technology Corp. | 1979-12-31 | Traditional | PDF ↗ |
| K781968 | BLOOD GAS SYSTEM MODEL 168 | Corning Medical & Scientific | 1979-01-03 | Traditional | PDF ↗ |
| K780716 | TECHNICON BGII ANALYZER | Technicon Instruments Corp. | 1978-06-14 | Traditional | PDF ↗ |
| K772307 | PCO 2 ELECTROLYTE | Fisher Scientific Co., LLC | 1977-12-22 | Traditional | PDF ↗ |
| K771822 | BG II ANALYZER | Technicon Instruments Corp. | 1977-10-19 | Traditional | PDF ↗ |
| K771147 | AVL BLOOD GAS INSTRUMENT MODEL 939 | Jones Medical Instrument Co. | 1977-09-15 | Traditional | PDF ↗ |
| K771253 | HEMOX-ANALYZER | 3M Company | 1977-08-25 | Traditional | PDF ↗ |
| K770736 | MONITOR, PATIENT, MODEL PM-20N | Cavitron Corp. | 1977-06-02 | Traditional | PDF ↗ |
| K760969 | PH/BLOOD GAS SYSTEM | Instrumentation Laboratory CO | 1977-01-12 | Traditional | PDF ↗ |
| K760748 | REAGENTS FOR BLOOD GAS INSTRUMENTATION | Alko Scientific Co. | 1976-11-01 | Traditional | PDF ↗ |
| K760229 | ACID BASE SYSTEM, RADIOMETER AUTOMATED | The London Co. | 1976-08-26 | Traditional | PDF ↗ |
Product code CHL · Class II · Clinical Chemistry. Data: openFDA.