Product code DDB
- Device name
- Ceruloplasmin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5210
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161508 | Ceruloplasmin | Beckman Coulter Ireland, Inc. | 2017-01-09 |
| K122965 | HUMAN CAERULOPLASMIN KIT | The Binding Site Group , Ltd. | 2013-06-03 |
| K053074 | N ANTISERA TO HUMAN CERULOPLASMIN | Dade Behring, Inc. | 2006-03-16 |
| K964762 | IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT | Beckman Instruments, Inc. | 1997-04-25 |
| K913668 | CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | 1991-12-20 |
| K895377 | QM300 CERULOPLASMIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1989-09-21 |
| K860138 | NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM | Sigma Diagnostics, Inc. | 1986-03-28 |
| K850682 | 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL | Kent Laboratories, Inc. | 1985-11-25 |
| K852247 | LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) | Behring Diagnostics, Inc. | 1985-07-10 |
| K851283 | RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN | Cooper Biomedical, Inc. | 1985-05-23 |
| K823107 | QUANTIMETRIC 2 CERULOPLASMIN ASSAY | Kallestad Laboratories, Inc. | 1982-11-16 |
| K812486 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL | Dako Corp. | 1981-09-23 |
| K801661 | J.T. BAKER CERULOPLASMIN NEPHELOMETRIC | J.T. Baker Chemical Co. | 1980-09-16 |
| K790712 | ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI | Kent Laboratories, Inc. | 1979-08-16 |
| K790714 | ANTISERUM TO HUMAN CERULOPLASMIN | Kent Laboratories, Inc. | 1979-08-16 |
| K791339 | HUMAN CERULOPLASMIN | Beckman Instruments, Inc. | 1979-08-16 |
| K781024 | CERUOPLASMIN SERUM ANTI-HUMAN | Icl Scientific | 1978-08-14 |
| K772255 | CERULOPLASMIN NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1978-01-05 |
| K771795 | LAS-R CERULOPLASMIN TEST | Hyland Therapeutic Div., Travenol Laboratories | 1977-11-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05055273207071 | CERULOPLASMIN (CPL) | RANDOX LABORATORIES LIMITED | 2019-06-03 |
| 15099590010614 | AU | Beckman Coulter, Inc. | 2017-02-17 |
| B1761260 | Antiserum to Human Ceruloplasmin | KENT LABORATORIES INC | 2016-09-24 |
| 05051700010719 | Human Caeruloplasmin NL BINDARID™ Radial Immunodiffusion Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700016346 | Human Caeruloplasmin Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700018197 | Optilite Caeruloplasmin Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 00842768011382 | N Antiserum to Human Ceruloplasmin | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 15099590224080 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |