JMG — Radioimmunoassay (Two-Site Solid Phase), Ferritin Class II
FDA Device Classification
Classification Details
- Product Code
- JMG
- Device Class
- Class II
- Regulation Number
- 866.5340
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K234052 | beckman coulter | Access Ferritin | March 20, 2024 |
| K052082 | beckman coulter | FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 | August 19, 2005 |
| K964282 | boehringer mannheim | TINA-QUANT FERRITIN ASSAY | July 30, 1997 |
| K971833 | boehringer mannheim | ELECSYS FERRITIN | June 2, 1997 |
| K963498 | dade chemistry systems | FERR FLEX REAGENT CARTRIDGE | January 24, 1997 |
| K950393 | schiapparelli biosystems | ACE(TM) CEDIA(R) FERRITIN ASSAY | May 16, 1995 |
| K925848 | diagnostic products | IMMULITE FERRITIN | January 13, 1993 |
| K926221 | bio-rad laboratories | ACCESS FERRITIN ASSAY | January 13, 1993 |
| K920829 | roche diagnostic systems | COBAS CORE FERRITIN EIA | June 19, 1992 |
| K920318 | microgenics | CEDIA FERRITIN ASSAY | June 4, 1992 |
| K902997 | diagnostic products | MILENIA (TM) FERRITIN | August 2, 1990 |
| K890697 | cambridge medical technology | RIA-GNOST FERRITIN | March 16, 1989 |
| K881138 | baxter healthcare | CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. | April 21, 1988 |
| K873730 | medix biotech | MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT | November 4, 1987 |
| K872955 | lkb instruments | DELFIA(TM) FERRITIN KIT | August 21, 1987 |
| K840460 | corning medical and scientific | CORNINGS MAGIC FERRITIN RADIOIMMUNO- | March 30, 1984 |
| K810799 | bio-rad | QUANTIMUNE FERRITIN IRMA | April 3, 1981 |
| K792588 | bd becton dickinson vacutainer systems preanalytic | TERRITIN RIA KIT | January 11, 1980 |
| K791096 | corning medical and scientific | RADIOIMMUNOASSAY TEST SYSTEM | August 3, 1979 |
| K782157 | nordiclab intl | IRMA TEST, NORDICLAB FERRITIN | January 17, 1979 |