Rabbit Antiserum to Human Iga
FDA 510(k) K831909 · Dako Corp.
510(k) numberK831909
Submission
- Device name
- Rabbit Antiserum to Human Iga
- Applicant
- Dako Corp.
Mchenry, IL, US - Received
- June 14, 1983
- Decision date
- July 18, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CZN – Iga, Fitc, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code CZN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891683 | Titan Gel Ife Free Kappa/Lamba Light Chain AntiserCZN · Traditional | Helena Laboratories | 04/12/1989SE |
| K855011 | Quantimetric Plus C3 Reagent KitCZN · Traditional | Kallestad Laboratories, Inc. | 02/26/1986SE |
| K841815 | Optimate Iga TestCZN · Traditional | Miles Laboratories, Inc. | 06/01/1984SE |
| K832262 | Fitc Goat Anti-Human ImmunoglobulinsCZN · Traditional | Gelco Diagnostics, Inc. | 10/31/1983SE |
| K832257 | Goat Anti-Human Iga a Chain SpecificCZN · Traditional | Gelco Diagnostics, Inc. | 10/28/1983SE |
| K831607 | Fiax Iga Test KitCZN · Traditional | Intl. Diagnostic Technology | 06/22/1983SE |
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| K993957 | Dako Monoclonal Mouse Anti-Human Estrogen ReceptorMYA · Traditional | 03/03/2000SE |
| K991454 | Mouse IGG1 Negative ControlsGKZ · Traditional | 06/21/1999SE |
| K991402 | Dako Mouse Anti-Human T-Cell, CD3/RPE-CY5, Clone UCHT1 & Dako Mouse Anti-Human T-Cell…GKZ · Traditional | 06/21/1999SE |
| 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 |
| K965022 | Monoclonal Mouse Anti-Human CD30, KI-1 Antigen, BER-H2 Antibody for Immunoenzymatic…DEH · Traditional | 11/06/1997SE |
| 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 Rabbit Antiserum to Human Iga cleared by the FDA?
Rabbit Antiserum to Human Iga (K831909) received a 510(k) decision of Substantially Equivalent on July 18, 1983, 34 days after the submission was received.
What is the product code of K831909?
The FDA product code is CZN – Iga, Fitc, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.