Ceruoplasmin Serum Anti-Human
FDA 510(k) K781024 · Icl Scientific
510(k) numberK781024
Submission
- Device name
- Ceruoplasmin Serum Anti-Human
- Applicant
- Icl Scientific
Mchenry, IL, US - Received
- June 19, 1978
- Decision date
- August 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DDB – Ceruloplasmin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5210
- Specialty
- Immunology
Other 510(k)s with product code DDB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161508 | CeruloplasminDDB · Traditional | Beckman Coulter Ireland, Inc. | 01/09/2017SE |
| K122965 | Human Caeruloplasmin KitDDB · Traditional | The Binding Site Group , Ltd. | 06/03/2013SE |
| K053074 | N Antisera to Human CeruloplasminDDB · Traditional | Dade Behring, Inc. | 03/16/2006SE |
| K964762 | Immage Immunochemistry System Ceruloplasmin (Cer) ReagentDDB · Traditional | Beckman Instruments, Inc. | 04/25/1997SE |
| K913668 | Caeruloplasmin Immunological NL Test KitDDB · Traditional | The Binding Site, Ltd. | 12/20/1991SE |
| K895377 | QM300 Ceruloplasmin Antibody PackDDB · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 09/21/1989SE |
| K860138 | No. 615 Determination of Ceruloplasmin in SerumDDB · Traditional | Sigma Diagnostics, Inc. | 03/28/1986SE |
| K850682 | 72 Determ. Size Radial Immuno. Test Human CeruloplDDB · Traditional | Kent Laboratories, Inc. | 11/25/1985SE |
| K852247 | Laser Ceruloplasmin Kit(Ceruloplasmin Reagents)DDB · Traditional | Behring Diagnostics, Inc. | 07/10/1985SE |
| K851283 | Radial Immunodiffusion Plates-CeruloplasminDDB · Traditional | Cooper Biomedical, Inc. | 05/23/1985SE |
More from Cooper Biomedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883942 | Hycor Sentry Drugs of Abuse Urine ControlJJY · Traditional | 11/10/1988SE |
| K843565 | Kova Trol I,Ii, III Human Urine-DriedJJW · Traditional | 10/05/1984SE |
| K833761 | Therapeutic Drug ControlDKB · Traditional | 01/13/1984SE |
| K832823 | Enzymune-Test TSHJLW · Traditional | 10/14/1983SE |
| K831383 | Event-Test SlideJHJ · Traditional | 06/22/1983SE |
| K823199 | Enzyme-Test DigoxinKXT · Traditional | 11/29/1982SE |
| K822777 | Therapeutic Drug ControlDIF · Traditional | 10/08/1982SE |
| K822346 | Histimune Enzyme-Ana TestLJM · Traditional | 10/08/1982SE |
| K822465 | Enzymune System IJJE · Traditional | 09/14/1982SE |
| K821374 | Enzymune-Test InsulinCFP · Traditional | 05/28/1982SE |
Questions and answers
When was Ceruoplasmin Serum Anti-Human cleared by the FDA?
Ceruoplasmin Serum Anti-Human (K781024) received a 510(k) decision of Substantially Equivalent on August 14, 1978, 56 days after the submission was received.
What is the product code of K781024?
The FDA product code is DDB – Ceruloplasmin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5210.