FDA Product Code
FDA Product Code JFP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1145
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230300 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-10-27 | Traditional | PDF ↗ |
| K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-02-14 | Traditional | PDF ↗ |
| K191626 | Stat Profile Prime ES Comp Plus Analyzer System | Nova Biomedical Corporation | 2019-08-16 | Traditional | PDF ↗ |
| K152327 | EasyLyte Na/K/Cl/Ca Analyzer | Medica Corporation | 2016-12-01 | Traditional | PDF ↗ |
| K984299 | AVL OPTI CRITICAL CARE ANALYZER | Avl Scientific Corp. | 1998-12-11 | Traditional | PDF ↗ |
| K972673 | AVL 9181 ELECTROLYTE ANALYZER | Avl Scientific Corp. | 1997-08-20 | Traditional | PDF ↗ |
| K963694 | EASYLYTE CALCIUM/CHLORIDE ANALYZER | Medica Corp. | 1996-11-27 | Traditional | PDF ↗ |
| K961458 | AVL 9180 ELECTROLYTE ANALYZER | Avl Scientific Corp. | 1996-06-12 | Traditional | PDF ↗ |
| K960120 | STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS | Nova Biomedical Corp. | 1996-03-11 | Traditional | PDF ↗ |
| K943091 | EASY LYTE CALCIUM ANALYZER | Medica Corp. | 1995-01-17 | Traditional | PDF ↗ |
| K943702 | AVL 988-4 ELECTROLYTE ANALYZER | Avl Scientific Corp. | 1994-09-09 | Traditional | PDF ↗ |
| K934642 | I-STAT IONIZED CALCIUM TEST | I-Stat Corp. | 1993-12-17 | Traditional | PDF ↗ |
| K915675 | ELECTRODE, ION SPECIFIC | Alko Diagnostic Corp. | 1992-04-29 | Traditional | PDF ↗ |
| K904726 | LYTENING TM 6/R | Amdev, Inc. | 1990-12-18 | Traditional | PDF ↗ |
| K896316 | EOS IONIZED CALCIUM TEST CARD | Eos Technology Corp. | 1990-02-13 | Traditional | PDF ↗ |
| K895397 | CALCIUM AND PH ELECTROLYTE ANALYZER | Ionetics, Inc. | 1989-12-12 | Traditional | PDF ↗ |
| K884771 | IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY | Instrumentation Laboratory CO | 1989-02-10 | Traditional | PDF ↗ |
| K884731 | LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ | Amdev, Inc. | 1989-02-03 | Traditional | PDF ↗ |
| K880973 | MICROLYTE 7 | The Rupp & Bowman Co. | 1988-09-07 | Traditional | PDF ↗ |
| K873345 | 'MICROLYTE 4/5' | Kone Instruments, Inc. | 1987-09-11 | Traditional | PDF ↗ |
| K860639 | IONIZED CALCIUM AND BLOOD PH TESTCARDS | Ilex Corp. | 1986-04-21 | Traditional | PDF ↗ |
| K844188 | CORNING CALCIUM PH ANALYZER 634 | Corning Medical & Scientific | 1985-02-04 | Traditional | PDF ↗ |
| K830213 | NOVA 7 TOTAL CALCIUM/IONIZED CALCIUM | Nova Biomedical Corp. | 1983-04-05 | Traditional | PDF ↗ |
| K830502 | NOVA 8 IONIZED CALCIUM/PH ANALYZER | Nova Biomedical Corp. | 1983-03-24 | Traditional | PDF ↗ |
| K823389 | SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ | Nova Biomedical Corp. | 1983-02-02 | Traditional | PDF ↗ |
| K810203 | MODEL AM 722 | Applied Medical Technologies | 1981-02-10 | Traditional | PDF ↗ |
| K802856 | MINIATURE ION SELECTIVE ELECTRODES | Ionetics, Inc. | 1981-01-28 | Traditional | PDF ↗ |
| K801848 | ICA1 IONIZED CALCIUM ANALYZER | The London Co. | 1980-10-31 | Traditional | PDF ↗ |
| K771643 | NOVA 2 IONIZED CALCIUM ANALYZER | Nova Biomedical Corp. | 1977-09-28 | Traditional | PDF ↗ |
Product code JFP · Class II · Clinical Chemistry. Data: openFDA.