Dako Ita, Immunoglobulin M (Igm)
FDA 510(k) K862184 · Dako Corp.
510(k) numberK862184
Submission
- Device name
- Dako Ita, Immunoglobulin M (Igm)
- Applicant
- Dako Corp.
Santa Barbara, CA, US - Received
- June 9, 1986
- Decision date
- August 19, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DAH – Gamma Globulin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DAH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931247 | Titan Gel IMMUNOFIX-9 Cat. No. 3051 and 3067DAH · Traditional | Helena Laboratories | 04/27/1993SE |
| K905149 | Titan GelDAH · Traditional | Helena Laboratories | 01/03/1991SE |
| K901805 | Rep(R) ImmunofixDAH · Traditional | Helena Laboratories | 06/06/1990SE |
| K884074 | Immunochemical Determination of Immunoglobulin GDAH · Traditional | Orion Diagnostica, Inc. | 10/27/1988SE |
| K883494 | Technicon DPA-1 Immunoglobulin GDAH · Traditional | Technicon Instruments Corp. | 09/07/1988SE |
| K854944 | TDX Immunoglobulin M Diagnostic KitDAH · Traditional | Abbott Laboratories | 08/27/1986SE |
More from Abbott Laboratories
| 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 Dako Ita, Immunoglobulin M (Igm) cleared by the FDA?
Dako Ita, Immunoglobulin M (Igm) (K862184) received a 510(k) decision of Substantially Equivalent on August 19, 1986, 71 days after the submission was received.
What is the product code of K862184?
The FDA product code is DAH – Gamma Globulin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.