Product code JMG— Immunology

FDA has cleared 24 devices under product code JMG between 1978 and 2024, filed by 19 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.

• 20241 clearance
• 20051 clearance
• 19973 clearances
• 19951 clearance
• 19932 clearances
• 19922 clearances
• 19901 clearance
• 19891 clearance
• 19881 clearance
• 19872 clearances
• 19841 clearance
• 19811 clearance
• 19801 clearance
• 19795 clearances
• 19781 clearance

• Diagnostic Products Corp.2 clearances
• Corning Medical & Scientific2 clearances
• Boehringer Mannheim Corp.2 clearances
• Beckman Coulter, Inc.2 clearances
• Bd Becton Dickinson Vacutainer Systems Preanalytic2 clearances
• Schiapparelli Biosystems, Inc.1 clearance
• Roche Diagnostic Systems, Inc.1 clearance
• Ria Products, Inc.1 clearance
• Nordiclab Intl.1 clearance
• New England Nuclear1 clearance

• K234052 — Access FerritinBeckman Coulter, Inc.·2024-03-20
• K052082 — FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020Beckman Coulter, Inc.·2005-08-19
• K964282 — TINA-QUANT FERRITIN ASSAYBoehringer Mannheim Corp.·1997-07-30
• K971833 — ELECSYS FERRITINBoehringer Mannheim Corp.·1997-06-02
• K963498 — FERR FLEX REAGENT CARTRIDGEDade Chemistry Systems, Inc.·1997-01-24
• K950393 — ACE(TM) CEDIA(R) FERRITIN ASSAYSchiapparelli Biosystems, Inc.·1995-05-16
• K925848 — IMMULITE FERRITINDiagnostic Products Corp.·1993-01-13
• K926221 — ACCESS FERRITIN ASSAYBio-Rad Laboratories, Inc.·1993-01-13
• K920829 — COBAS CORE FERRITIN EIARoche Diagnostic Systems, Inc.·1992-06-19
• K920318 — CEDIA FERRITIN ASSAYMicrogenics Corp.·1992-06-04
• K902997 — MILENIA (TM) FERRITINDiagnostic Products Corp.·1990-08-02
• K890697 — RIA-GNOST FERRITINCambridge Medical Technology·1989-03-16
• K881138 — CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.Baxter Healthcare Corp·1988-04-21
• K873730 — MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.·1987-11-04
• K872955 — DELFIA(TM) FERRITIN KITLkb Instruments, Inc.·1987-08-21
• K840460 — CORNINGS MAGIC FERRITIN RADIOIMMUNO-Corning Medical & Scientific·1984-03-30
• K810799 — QUANTIMUNE FERRITIN IRMABio-Rad·1981-04-03
• K792588 — TERRITIN RIA KITBd Becton Dickinson Vacutainer Systems Preanalytic·1980-01-11
• K791096 — RADIOIMMUNOASSAY TEST SYSTEMCorning Medical & Scientific·1979-08-03
• K782157 — IRMA TEST, NORDICLAB FERRITINNordiclab Intl.·1979-01-17
• K781844 — FERRITIN KITRia Products, Inc.·1979-01-10
• K781888 — ASSAY SYSTEM, FERRITIN I KITNew England Nuclear·1979-01-10
• K781946 — RIA KIT, FERRITIN SOLID PHASEBd Becton Dickinson Vacutainer Systems Preanalytic·1979-01-10
• K781527 — RIA SYSTEM FOR HUMAN FE-RITINCalbiochem-Behring Corp.·1978-10-03