Product code JFP— Clinical Chemistry

FDA has cleared 29 devices under product code JFP between 1977 and 2023, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20231 clearance
• 20201 clearance
• 20191 clearance
• 20161 clearance
• 19981 clearance
• 19971 clearance
• 19963 clearances
• 19951 clearance
• 19941 clearance
• 19931 clearance
• 19921 clearance
• 19902 clearances
• 19893 clearances
• 19881 clearance
• 19871 clearance

• Nova Biomedical Corp.5 clearances
• Avl Scientific Corp.4 clearances
• Medica Corp.2 clearances
• Ionetics, Inc.2 clearances
• Amdev, Inc.2 clearances
• Abbott Point of Care, Inc.2 clearances
• The Rupp & Bowman Co.1 clearance
• The London Co.1 clearance
• Nova Biomedical Corporation1 clearance
• Medica Corporation1 clearance

• K230300 — i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.·2023-10-27
• K191360 — i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.·2020-02-14
• K191626 — Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical Corporation·2019-08-16
• K152327 — EasyLyte Na/K/Cl/Ca AnalyzerMedica Corporation·2016-12-01
• K984299 — AVL OPTI CRITICAL CARE ANALYZERAvl Scientific Corp.·1998-12-11
• K972673 — AVL 9181 ELECTROLYTE ANALYZERAvl Scientific Corp.·1997-08-20
• K963694 — EASYLYTE CALCIUM/CHLORIDE ANALYZERMedica Corp.·1996-11-27
• K961458 — AVL 9180 ELECTROLYTE ANALYZERAvl Scientific Corp.·1996-06-12
• K960120 — STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERSNova Biomedical Corp.·1996-03-11
• K943091 — EASY LYTE CALCIUM ANALYZERMedica Corp.·1995-01-17
• K943702 — AVL 988-4 ELECTROLYTE ANALYZERAvl Scientific Corp.·1994-09-09
• K934642 — I-STAT IONIZED CALCIUM TESTI-Stat Corp.·1993-12-17
• K915675 — ELECTRODE, ION SPECIFICAlko Diagnostic Corp.·1992-04-29
• K904726 — LYTENING TM 6/RAmdev, Inc.·1990-12-18
• K896316 — EOS IONIZED CALCIUM TEST CARDEos Technology Corp.·1990-02-13
• K895397 — CALCIUM AND PH ELECTROLYTE ANALYZERIonetics, Inc.·1989-12-12
• K884771 — IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALYInstrumentation Laboratory CO·1989-02-10
• K884731 — LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZAmdev, Inc.·1989-02-03
• K880973 — MICROLYTE 7The Rupp & Bowman Co.·1988-09-07
• K873345 — 'MICROLYTE 4/5'Kone Instruments, Inc.·1987-09-11
• K860639 — IONIZED CALCIUM AND BLOOD PH TESTCARDSIlex Corp.·1986-04-21
• K844188 — CORNING CALCIUM PH ANALYZER 634Corning Medical & Scientific·1985-02-04
• K830213 — NOVA 7 TOTAL CALCIUM/IONIZED CALCIUMNova Biomedical Corp.·1983-04-05
• K830502 — NOVA 8 IONIZED CALCIUM/PH ANALYZERNova Biomedical Corp.·1983-03-24
• K823389 — SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZNova Biomedical Corp.·1983-02-02
• K810203 — MODEL AM 722Applied Medical Technologies·1981-02-10
• K802856 — MINIATURE ION SELECTIVE ELECTRODESIonetics, Inc.·1981-01-28
• K801848 — ICA1 IONIZED CALCIUM ANALYZERThe London Co.·1980-10-31
• K771643 — NOVA 2 IONIZED CALCIUM ANALYZERNova Biomedical Corp.·1977-09-28