Goat Anti-Human Immunoglobulins-
FDA 510(k) K832256 · Gelco Diagnostics, Inc.
510(k) numberK832256
Submission
- Device name
- Goat Anti-Human Immunoglobulins-
- Applicant
- Gelco Diagnostics, Inc.
Mchenry, IL, US - Received
- June 30, 1983
- Decision date
- October 31, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DFH – Kappa, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
Other 510(k)s with product code DFH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light…DFH · Traditional | Diazyme Laboratories, Inc. | 12/19/2025SE |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitDFH · Traditional | The Binding Site Group , Ltd. | 05/23/2025SE |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2DFH · Traditional | Sebia | 02/23/2024SE |
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitDFH · Traditional | The Binding Site, Ltd. | 01/24/2024SE |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2DFH · Traditional | Sebia | 11/18/2022SE |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | Diazyme Laboratories, Inc. | 09/08/2022SE |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | Diazyme Laboratories, Inc. | 08/04/2022SE |
| K212379 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | Siemens Healthcare Diagnostics Products GmbH | 03/02/2022SE |
| K201496 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | Siemens Healthcare Diagnostics Products GmbH | 10/29/2021SE |
| K193047 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | Siemens Healthcare Diagnostics Products GmbH | 07/14/2021SE |
More from Siemens Healthcare Diagnostics Products GmbH
| 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 |
| K832260 | Goat Anti-Human Kappa AffinityDEO · Traditional | 10/31/1983SE |
| K832258 | Goat Anti-Human Igg Y Chain SpecificDEW · 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 Immunoglobulins- cleared by the FDA?
Goat Anti-Human Immunoglobulins- (K832256) 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 K832256?
The FDA product code is DFH – Kappa, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.