Antiserum to Rabbit Igg H & L Chain
FDA 510(k) K790706 · Kent Laboratories, Inc.
510(k) numberK790706
Submission
- Device name
- Antiserum to Rabbit Igg H & L Chain
- Applicant
- Kent Laboratories, Inc.
Mchenry, IL, US - Received
- April 12, 1979
- Decision date
- September 12, 1979
- 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
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| 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 |
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|---|---|---|
| K951966 | Human Prealbumin Radial Immunodiffusion KitJZJ · Traditional | 06/01/1995SE |
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| K951967 | Human C1 Inactivator or C-1 Esterase Inhibitor Radial Immunodiffusion KitDBA · Traditional | 05/30/1995SE |
| K950102 | Human C-5 Radial Immunodiffusion KitDAY · Traditional | 04/10/1995SE |
| K850683 | 72 Determ. Size Radial Immunodiffusion Test ALPHA2DEB · Traditional | 11/27/1985SE |
| K850682 | 72 Determ. Size Radial Immuno. Test Human CeruloplDDB · Traditional | 11/25/1985SE |
| K850691 | Antiserum to Human Apolipoprotein A-IMSJ · Traditional | 11/01/1985SE |
| K850690 | Antiserum to Human Apolipoprotein BMSJ · Traditional | 11/01/1985SE |
| K850686 | Antiserum to Human PrealbuminJZJ · Traditional | 11/01/1985SE |
| K831961 | Immunodiffusion Test Human AntithrombinJBQ · Traditional | 08/11/1983SE |
Questions and answers
When was Antiserum to Rabbit Igg H & L Chain cleared by the FDA?
Antiserum to Rabbit Igg H & L Chain (K790706) received a 510(k) decision of Substantially Equivalent on September 12, 1979, 153 days after the submission was received.
What is the product code of K790706?
The FDA product code is DFH – Kappa, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.