JMG — Radioimmunoassay (Two-Site Solid Phase), Ferritin Class II
FDA product code JMG covers "Radioimmunoassay (Two-Site Solid Phase), Ferritin", a Class II medical device regulated under 21 CFR 866.5340. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K926221 | bio-rad laboratories | ACCESS FERRITIN ASSAY | January 13, 1993 |
| K925848 | diagnostic products | IMMULITE FERRITIN | 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 |