Goat Anti-Human Kappa Affinity
FDA 510(k) K832260 · Gelco Diagnostics, Inc.
510(k) numberK832260
Submission
- Device name
- Goat Anti-Human Kappa Affinity
- Applicant
- Gelco Diagnostics, Inc.
Walker, MI, US - Received
- June 30, 1983
- Decision date
- October 31, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DEO – Kappa, Fitc, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
Other 510(k)s with product code DEO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831904 | Rabbit Antiserum to Human Kappa LightDEO · Traditional | Dako Corp. | 07/19/1983SE |
More from Dako Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K832270 | Goat Anti-Human LambaDEH · Traditional | 10/31/1983SE |
| K832267 | Fitc Goat Anti-Human LambaDES · Traditional | 10/31/1983SE |
| K832266 | Fitc Goat Anti-Human Kappa AffinityDFH · Traditional | 10/31/1983SE |
| K832265 | Fitc Goat Anti-Human Igm H ChainDFT · Traditional | 10/31/1983SE |
| K832263 | Fitc Goat Anti-Human Iga a ChainCZP · Traditional | 10/31/1983SE |
| K832262 | Fitc Goat Anti-Human ImmunoglobulinsCZN · Traditional | 10/31/1983SE |
| K832258 | Goat Anti-Human Igg Y Chain SpecificDEW · Traditional | 10/31/1983SE |
| K832256 | Goat Anti-Human Immunoglobulins-DFH · Traditional | 10/31/1983SE |
| K832264 | Fitc Goat Anti-Human Igg Y ChainDEW · Traditional | 10/28/1983SE |
| K832261 | Goat Anti-Human Lamba AffinityDEH · Traditional | 10/28/1983SE |
Questions and answers
When was Goat Anti-Human Kappa Affinity cleared by the FDA?
Goat Anti-Human Kappa Affinity (K832260) received a 510(k) decision of Substantially Equivalent on October 31, 1983, 123 days after the submission was received.
What is the product code of K832260?
The FDA product code is DEO – Kappa, Fitc, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.