Product code JFP
- Device name
- Electrode, Ion Specific, Calcium
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1145
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230300 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-10-27 |
| K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-02-14 |
| K191626 | Stat Profile Prime ES Comp Plus Analyzer System | Nova Biomedical Corporation | 2019-08-16 |
| K152327 | EasyLyte Na/K/Cl/Ca Analyzer | Medica Corporation | 2016-12-01 |
| K984299 | AVL OPTI CRITICAL CARE ANALYZER | Avl Scientific Corp. | 1998-12-11 |
| K972673 | AVL 9181 ELECTROLYTE ANALYZER | Avl Scientific Corp. | 1997-08-20 |
| K963694 | EASYLYTE CALCIUM/CHLORIDE ANALYZER | Medica Corp. | 1996-11-27 |
| K961458 | AVL 9180 ELECTROLYTE ANALYZER | Avl Scientific Corp. | 1996-06-12 |
| K960120 | STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS | Nova Biomedical Corp. | 1996-03-11 |
| K943091 | EASY LYTE CALCIUM ANALYZER | Medica Corp. | 1995-01-17 |
| K943702 | AVL 988-4 ELECTROLYTE ANALYZER | Avl Scientific Corp. | 1994-09-09 |
| K934642 | I-STAT IONIZED CALCIUM TEST | I-Stat Corp. | 1993-12-17 |
| K915675 | ELECTRODE, ION SPECIFIC | Alko Diagnostic Corp. | 1992-04-29 |
| K904726 | LYTENING TM 6/R | Amdev, Inc. | 1990-12-18 |
| K896316 | EOS IONIZED CALCIUM TEST CARD | Eos Technology Corp. | 1990-02-13 |
| K895397 | CALCIUM AND PH ELECTROLYTE ANALYZER | Ionetics, Inc. | 1989-12-12 |
| K884771 | IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY | Instrumentation Laboratory CO | 1989-02-10 |
| K884731 | LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ | Amdev, Inc. | 1989-02-03 |
| K880973 | MICROLYTE 7 | The Rupp & Bowman Co. | 1988-09-07 |
| K873345 | 'MICROLYTE 4/5' | Kone Instruments, Inc. | 1987-09-11 |
| K860639 | IONIZED CALCIUM AND BLOOD PH TESTCARDS | Ilex Corp. | 1986-04-21 |
| K844188 | CORNING CALCIUM PH ANALYZER 634 | Corning Medical & Scientific | 1985-02-04 |
| K830213 | NOVA 7 TOTAL CALCIUM/IONIZED CALCIUM | Nova Biomedical Corp. | 1983-04-05 |
| K830502 | NOVA 8 IONIZED CALCIUM/PH ANALYZER | Nova Biomedical Corp. | 1983-03-24 |
| K823389 | SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ | Nova Biomedical Corp. | 1983-02-02 |
| K810203 | MODEL AM 722 | Applied Medical Technologies | 1981-02-10 |
| K802856 | MINIATURE ION SELECTIVE ELECTRODES | Ionetics, Inc. | 1981-01-28 |
| K801848 | ICA1 IONIZED CALCIUM ANALYZER | The London Co. | 1980-10-31 |
| K771643 | NOVA 2 IONIZED CALCIUM ANALYZER | Nova Biomedical Corp. | 1977-09-28 |
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|---|---|---|---|
| 10054749005519 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-05-01 |
| 08426950807582 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 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 |
| 08426950807803 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 450 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807797 | GEM Premier 5000 PAK BG/ISE/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 |
| 08426950807759 | GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807742 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 300 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807735 | GEM Premier 5000 PAK BG/ISE/COOX 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 |
| 08426950807681 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 150 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807674 | GEM Premier 5000 PAK BG/ISE/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 |
| 08426950807629 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807612 | GEM Premier 5000 PAK BG/ISE/COOX 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 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 |
| 08426950807698 | GEM Premier 5000 PAK BG/ISE/GL/COOX 150 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807575 | GEM Premier 5000 PAK BG/ISE/COOX 600 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 00385480118026 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-22 |
| 00385480131940 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480128827 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480131971 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480131438 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480115339 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480112727 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480095839 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 10054749000163 | i-STAT | ABBOTT POINT OF CARE INC. | 2016-09-09 |