Rabbit Antiserum to Human Igm
FDA 510(k) K831907 · Dako Corp.
510(k) numberK831907
Submission
- Device name
- Rabbit Antiserum to Human Igm
- Applicant
- Dako Corp.
Mchenry, IL, US - Received
- June 14, 1983
- Decision date
- July 19, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DFS – Igm, Fitc, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
More from Dako Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K020023 | Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for…MXZ · Traditional | 02/28/2002SE |
| 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 Igm cleared by the FDA?
Rabbit Antiserum to Human Igm (K831907) received a 510(k) decision of Substantially Equivalent on July 19, 1983, 35 days after the submission was received.
What is the product code of K831907?
The FDA product code is DFS – Igm, Fitc, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.