Iga Immunoturbidimetric & Calibrator
FDA 510(k) K955794 · Randox Laboratories, Ltd.
510(k) numberK955794
Submission
- Device name
- Iga Immunoturbidimetric & Calibrator
- Applicant
- Randox Laboratories, Ltd.
Crumlin, IE - Received
- December 22, 1995
- Decision date
- April 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CZP – Iga, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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|---|---|---|---|
| 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 |
| K955907 | Boehringer Mannheim Iga AssayCZP · Traditional | Boehringer Mannheim Corp. | 02/09/1996SE |
| K952309 | N Latex IgaCZP · Traditional | Behring Diagnostics, Inc. | 06/20/1995SE |
| K931806 | Iga Subclass Rid Kit for Diagnostic UseCZP · Traditional | The Binding Site, Ltd. | 07/16/1993SE |
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Questions and answers
When was Iga Immunoturbidimetric & Calibrator cleared by the FDA?
Iga Immunoturbidimetric & Calibrator (K955794) received a 510(k) decision of Substantially Equivalent on April 5, 1996, 105 days after the submission was received.
What is the product code of K955794?
The FDA product code is CZP – Iga, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.