JFP — Electrode, Ion Specific, Calcium Class II
FDA Device Classification
Classification Details
- Product Code
- JFP
- Device Class
- Class II
- Regulation Number
- 862.1145
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K230300 | abbott point of care | i-STAT CG8+ cartridge with the i-STAT 1 System | October 27, 2023 |
| K191360 | abbott point of care | i-STAT CHEM8+ cartridge with the i-STAT 1 System | February 14, 2020 |
| K191626 | nova biomedical corporation | Stat Profile Prime ES Comp Plus Analyzer System | August 16, 2019 |
| K152327 | medica corporation | EasyLyte Na/K/Cl/Ca Analyzer | December 1, 2016 |
| K984299 | avl scientific | AVL OPTI CRITICAL CARE ANALYZER | December 11, 1998 |
| K972673 | avl scientific | AVL 9181 ELECTROLYTE ANALYZER | August 20, 1997 |
| K963694 | medica | EASYLYTE CALCIUM/CHLORIDE ANALYZER | November 27, 1996 |
| K961458 | avl scientific | AVL 9180 ELECTROLYTE ANALYZER | June 12, 1996 |
| K960120 | nova biomedical | STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS | March 11, 1996 |
| K943091 | medica | EASY LYTE CALCIUM ANALYZER | January 17, 1995 |
| K943702 | avl scientific | AVL 988-4 ELECTROLYTE ANALYZER | September 9, 1994 |
| K934642 | i-stat | I-STAT IONIZED CALCIUM TEST | December 17, 1993 |
| K915675 | alko diagnostic | ELECTRODE, ION SPECIFIC | April 29, 1992 |
| K904726 | amdev | LYTENING TM 6/R | December 18, 1990 |
| K896316 | eos technology | EOS IONIZED CALCIUM TEST CARD | February 13, 1990 |
| K895397 | ionetics | CALCIUM AND PH ELECTROLYTE ANALYZER | December 12, 1989 |
| K884771 | instrumentation laboratory | IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY | February 10, 1989 |
| K884731 | amdev | LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ | February 3, 1989 |
| K880973 | rupp and bowman | MICROLYTE 7 | September 7, 1988 |
| K873345 | kone instruments | 'MICROLYTE 4/5' | September 11, 1987 |