510(k) K913668
- Device
- CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT
- Applicant
- THE BINDING SITE, LTD.
- 510(k) number
- K913668
- Product code
- DDB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-12-20
- Date received
- 1991-08-19
- Regulation
- 866.5210
- Classification name
- Ceruloplasmin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAY H GELLER
- Address
- Westside Towers, Suite 1000 11845 W. Olympic Blvd. Los Angeles CA US 90064 90064
FDA Registration Numbers#
- 3019906
- 2050012
- 2050010
- 9610806
- 9680746
- 3012471076
- 9614373
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DDB #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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