JFP · Electrode, Ion Specific, Calcium
Clinical Chemistry · 21 CFR 862.1145 · Class 2
Overview
| Product Code | JFP |
|---|---|
| Device Name | Electrode, Ion Specific, Calcium |
| Regulation | 21 CFR 862.1145 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Classification Rationale
Class II.
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230300 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Oct 27, 2023 | SESE |
| K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Feb 14, 2020 | SESE |
| K191626 | Stat Profile Prime ES Comp Plus Analyzer System | Nova Biomedical Corporation | Aug 16, 2019 | SESE |
| K152327 | EasyLyte Na/K/Cl/Ca Analyzer | Medica Corporation | Dec 1, 2016 | SESE |
| K984299 | AVL OPTI CRITICAL CARE ANALYZER | Avl Scientific Corp. | Dec 11, 1998 | SESE |
| K972673 | AVL 9181 ELECTROLYTE ANALYZER | Avl Scientific Corp. | Aug 20, 1997 | SESE |
| K963694 | EASYLYTE CALCIUM/CHLORIDE ANALYZER | Medica Corp. | Nov 27, 1996 | SESE |
| K961458 | AVL 9180 ELECTROLYTE ANALYZER | Avl Scientific Corp. | Jun 12, 1996 | SESE |
| K960120 | STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS | Nova Biomedical Corp. | Mar 11, 1996 | SESE |
| K943091 | EASY LYTE CALCIUM ANALYZER | Medica Corp. | Jan 17, 1995 | SESE |
| K943702 | AVL 988-4 ELECTROLYTE ANALYZER | Avl Scientific Corp. | Sep 9, 1994 | SESE |
| K934642 | I-STAT IONIZED CALCIUM TEST | I-Stat Corp. | Dec 17, 1993 | SESE |
| K915675 | ELECTRODE, ION SPECIFIC | Alko Diagnostic Corp. | Apr 29, 1992 | SESE |
| K904726 | LYTENING TM 6/R | Amdev, Inc. | Dec 18, 1990 | SESE |
| K896316 | EOS IONIZED CALCIUM TEST CARD | Eos Technology Corp. | Feb 13, 1990 | SESE |
| K895397 | CALCIUM AND PH ELECTROLYTE ANALYZER | Ionetics, Inc. | Dec 12, 1989 | SESE |
| K884771 | IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY | Instrumentation Laboratory CO | Feb 10, 1989 | SESE |
| K884731 | LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ | Amdev, Inc. | Feb 3, 1989 | SESE |
| K880973 | MICROLYTE 7 | The Rupp & Bowman Co. | Sep 7, 1988 | SESE |
| K873345 | 'MICROLYTE 4/5' | Kone Instruments, Inc. | Sep 11, 1987 | SESE |
Top Applicants
- Nova Biomedical Corp. — 5 clearances
- Avl Scientific Corp. — 4 clearances
- Abbott Point of Care, Inc. — 2 clearances
- Amdev, Inc. — 2 clearances
- Ionetics, Inc. — 2 clearances
