Immunogl. Frct. of Rabbit Antiser.-Iga
FDA 510(k) K812488 · Dako Corp.
510(k) numberK812488
Submission
- Device name
- Immunogl. Frct. of Rabbit Antiser.-Iga
- Applicant
- Dako Corp.
Mchenry, IL, US - Received
- August 31, 1981
- Decision date
- September 23, 1981
- 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
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|---|---|---|---|
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| 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 |
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| K991454 | Mouse IGG1 Negative ControlsGKZ · Traditional | 06/21/1999SE |
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| K980635 | Dako Mouse Anti-Human B-Cell, CD19/RPE-CY5, Clone HD37GKZ · Traditional | 07/22/1998SE |
| K971905 | Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal…DEH · Traditional | 12/12/1997SE |
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| K964974 | Mouse Anti-Human CD45, Leucocyte Common Antigen (Lca)/Fitc and CD14, Monocyte/RpeGKZ · Traditional | 06/24/1997SE |
| K961701 | Mouse Anti-Human CD3, T-Cell, Fitc and CD4, T-Cell, (Helper/Inducer) RpeGKZ · Traditional | 07/16/1996SE |
| K951965 | Dako Labeled Streptavidin-Biotin 2 Kit, and EnvisionDEH · Traditional | 07/05/1996SE |
Questions and answers
When was Immunogl. Frct. of Rabbit Antiser.-Iga cleared by the FDA?
Immunogl. Frct. of Rabbit Antiser.-Iga (K812488) received a 510(k) decision of Substantially Equivalent on September 23, 1981, 23 days after the submission was received.
What is the product code of K812488?
The FDA product code is CZP – Iga, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.