JFP — Electrode, Ion Specific, Calcium Class II
FDA product code JFP covers "Electrode, Ion Specific, Calcium", a Class II medical device regulated under 21 CFR 862.1145. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |