FDA Product Code
FDA Product Code DDB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5210
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K161508 | Ceruloplasmin | Beckman Coulter Ireland, Inc. | 2017-01-09 | Traditional | PDF ↗ |
| K122965 | HUMAN CAERULOPLASMIN KIT | The Binding Site Group , Ltd. | 2013-06-03 | Traditional | PDF ↗ |
| K053074 | N ANTISERA TO HUMAN CERULOPLASMIN | Dade Behring, Inc. | 2006-03-16 | Traditional | PDF ↗ |
| K964762 | IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT | Beckman Instruments, Inc. | 1997-04-25 | Traditional | PDF ↗ |
| K913668 | CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | 1991-12-20 | Traditional | PDF ↗ |
| K895377 | QM300 CERULOPLASMIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1989-09-21 | Traditional | PDF ↗ |
| K860138 | NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM | Sigma Diagnostics, Inc. | 1986-03-28 | Traditional | PDF ↗ |
| K850682 | 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL | Kent Laboratories, Inc. | 1985-11-25 | Traditional | PDF ↗ |
| K852247 | LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) | Behring Diagnostics, Inc. | 1985-07-10 | Traditional | PDF ↗ |
| K851283 | RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN | Cooper Biomedical, Inc. | 1985-05-23 | Traditional | PDF ↗ |
| K823107 | QUANTIMETRIC 2 CERULOPLASMIN ASSAY | Kallestad Laboratories, Inc. | 1982-11-16 | Traditional | PDF ↗ |
| K812486 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL | Dako Corp. | 1981-09-23 | Traditional | PDF ↗ |
| K801661 | J.T. BAKER CERULOPLASMIN NEPHELOMETRIC | J.T. Baker Chemical Co. | 1980-09-16 | Traditional | PDF ↗ |
| K790714 | ANTISERUM TO HUMAN CERULOPLASMIN | Kent Laboratories, Inc. | 1979-08-16 | Traditional | PDF ↗ |
| K791339 | HUMAN CERULOPLASMIN | Beckman Instruments, Inc. | 1979-08-16 | Traditional | PDF ↗ |
| K790712 | ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI | Kent Laboratories, Inc. | 1979-08-16 | Traditional | PDF ↗ |
| K781024 | CERUOPLASMIN SERUM ANTI-HUMAN | Icl Scientific | 1978-08-14 | Traditional | PDF ↗ |
| K772255 | CERULOPLASMIN NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1978-01-05 | Traditional | PDF ↗ |
| K771795 | LAS-R CERULOPLASMIN TEST | Hyland Therapeutic Div., Travenol Laboratories | 1977-11-14 | Traditional | PDF ↗ |
Product code DDB · Class II · Immunology. Data: openFDA.