J.T. Baker Ceruloplasmin Nephelometric
FDA 510(k) K801661 · J.T. Baker Chemical Co.
510(k) numberK801661
Submission
- Device name
- J.T. Baker Ceruloplasmin Nephelometric
- Applicant
- J.T. Baker Chemical Co.
Mchenry, IL, US - Received
- July 21, 1980
- Decision date
- September 16, 1980
- 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 |
|---|---|---|
| K803128 | Series 810 Platelet AnalyzerGKL · Traditional | 04/03/1981SE |
| K802080 | Baker Diag. Ultrarate Chloride KitJFS · Traditional | 10/10/1980SE |
| K802035 | Baker Diag. Ultrarate CO2 Reagent KitJFL · Traditional | 09/26/1980SE |
| K801909 | Lsa 290 Assay Reagents/NephelometricDEX · Traditional | 09/26/1980SE |
| K801795 | Baker Diagnostic Ultra-Rate Sodium/Pot.JGS · Traditional | 09/16/1980SE |
| K801669 | J.T. Baker ALPHA-1-ANTITRYPSIN NepheloDEM · Traditional | 09/16/1980SE |
| K801662 | J.T. Baker ALPHA-2-MACROGLOBULIN Neph.DEP · Traditional | 09/16/1980SE |
| K801362 | Albumin Nephelometric AssayJQX · Traditional | 07/21/1980SE |
| K801434 | J.T. Baker Transferrin Nephelometric AssDDG · Traditional | 07/08/1980SE |
| K801433 | Haptoglobin Nephelometric AssayDAD · Traditional | 07/08/1980SE |
Questions and answers
When was J.T. Baker Ceruloplasmin Nephelometric cleared by the FDA?
J.T. Baker Ceruloplasmin Nephelometric (K801661) received a 510(k) decision of Substantially Equivalent on September 16, 1980, 57 days after the submission was received.
What is the product code of K801661?
The FDA product code is DDB – Ceruloplasmin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5210.