DDB — Ceruloplasmin, Antigen, Antiserum, Control Class II
FDA product code DDB covers "Ceruloplasmin, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5210. Submissions are reviewed by the Immunology panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DDB
- Device Class
- Class II
- Regulation Number
- 866.5210
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K161508 | beckman coulter ireland | Ceruloplasmin | January 9, 2017 |
| K122965 | binding site group | HUMAN CAERULOPLASMIN KIT | June 3, 2013 |
| K053074 | dade behring | N ANTISERA TO HUMAN CERULOPLASMIN | March 16, 2006 |
| K964762 | beckman instruments | IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT | April 25, 1997 |
| K913668 | binding site | CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT | December 20, 1991 |
| K895377 | kallestad diag, a div. of erbamont | QM300 CERULOPLASMIN ANTIBODY PACK | September 21, 1989 |
| K860138 | sigma diagnostics | NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM | March 28, 1986 |
| K850682 | kent laboratories | 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL | November 25, 1985 |
| K852247 | behring diagnostics | LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) | July 10, 1985 |
| K851283 | cooper biomedical | RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN | May 23, 1985 |
| K823107 | kallestad laboratories | QUANTIMETRIC 2 CERULOPLASMIN ASSAY | November 16, 1982 |
| K812486 | dako | IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL | September 23, 1981 |
| K801661 | j.t. baker chemical | J.T. BAKER CERULOPLASMIN NEPHELOMETRIC | September 16, 1980 |
| K790714 | kent laboratories | ANTISERUM TO HUMAN CERULOPLASMIN | August 16, 1979 |
| K790712 | kent laboratories | ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI | August 16, 1979 |
| K791339 | beckman instruments | HUMAN CERULOPLASMIN | August 16, 1979 |
| K781024 | icl scientific | CERUOPLASMIN SERUM ANTI-HUMAN | August 14, 1978 |
| K772255 | kallestad laboratories | CERULOPLASMIN NEPHEL. ASSAY | January 5, 1978 |
| K771795 | hyland therapeutic div., travenol laboratories | LAS-R CERULOPLASMIN TEST | November 14, 1977 |