Radial Immunodiffusion Kit-Immunoglob.
FDA 510(k) K772076 · Gelman Instrument Co.
510(k) numberK772076
Submission
- Device name
- Radial Immunodiffusion Kit-Immunoglob.
- Applicant
- Gelman Instrument Co.
Mchenry, IL, US - Received
- November 3, 1977
- Decision date
- February 3, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CZP – Iga, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code CZP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…CZP · Traditional | Horiba Abx SAS | 06/26/2020SE |
| K060130 | Immage Systems Low Concentration Immunoglobulin a ReagentCZP · Special | Beckman Coulter, Inc. | 02/13/2006SE |
| K040435 | Roche Diagnostics Tina-Quant Iga GEN.2CZP · Special | Roche Diagnostics Corp. | 03/10/2004SE |
| K024038 | N Latex IgaCZP · Traditional | Dade Behring, Inc. | 02/13/2003SE |
| K993927 | Wako Iga Ii-Ha, Immunoglobulin Calibrator Set, Immunoglobulin StandradCZP · Traditional | Wako Chemicals USA, Inc. | 01/14/2000SE |
| K983359 | IgaCZP · Traditional | Abbott Laboratories | 11/04/1998SE |
| K962200 | Quantex IgaCZP · Traditional | Instrumentation Laboratory CO | 09/25/1996SE |
| K955794 | Iga Immunoturbidimetric & CalibratorCZP · Traditional | Randox Laboratories, Ltd. | 04/05/1996SE |
| K955907 | Boehringer Mannheim Iga AssayCZP · Traditional | Boehringer Mannheim Corp. | 02/09/1996SE |
| K952309 | N Latex IgaCZP · Traditional | Behring Diagnostics, Inc. | 06/20/1995SE |
More from Behring Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K772080 | Radial Immunodiffusion Kit-Alph-L-AntitDEM · Traditional | 02/03/1978SE |
| K772079 | Radial Immunodiffusion Kit-Immunoglob.MDFL · Traditional | 02/03/1978SE |
| K772078 | Radial Immunodiffusion Kit-HaptoglobinDAB · Traditional | 02/03/1978SE |
| K772077 | Radial Immunodiffusion Kit-Immunoglob.GDEW · Traditional | 02/03/1978SE |
| K772075 | Radial Immunodiffusion Kit-ComplementDAY · Traditional | 02/03/1978SE |
| K772074 | Radial Immunodiffusion Kit-TransferrinDDI · Traditional | 02/03/1978SE |
| K772073 | Radial Immunodiffusion Kit-Comp. 3DBI · Traditional | 02/03/1978SE |
| K772325 | Densitometer 18, Computing, Auto.JQT · Traditional | 01/12/1978SE |
| K771812 | Lippoprotein Electrophoresis Reagent SetDFC · Traditional | 10/18/1977SE |
| K770155 | Alkaline Phosphatase Isoyzme Reagent SetCJO · Traditional | 01/31/1977SE |
Questions and answers
When was Radial Immunodiffusion Kit-Immunoglob. cleared by the FDA?
Radial Immunodiffusion Kit-Immunoglob. (K772076) received a 510(k) decision of Substantially Equivalent on February 3, 1978, 92 days after the submission was received.
What is the product code of K772076?
The FDA product code is CZP – Iga, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.