Antiserum to Human Ig G FC Fragments
FDA 510(k) K790708 · Kent Laboratories, Inc.
510(k) numberK790708
Submission
- Device name
- Antiserum to Human Ig G FC Fragments
- Applicant
- Kent Laboratories, Inc.
Mchenry, IL, US - Received
- April 12, 1979
- Decision date
- August 22, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DAS – Igg (Fc Fragment Specific), Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5530
- Specialty
- Immunology
Other 510(k)s with product code DAS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K982023 | Pelicalss Human Igg Subclass Nephlometric Array KitDAS · Traditional | Inova Diagnostics, Inc. | 09/04/1998SE |
| K944876 | Human Igg Subclasses Nephelometric Bna KitDAS · Traditional | Research Diagnostics, Inc. | 12/15/1994SE |
| K943205 | Human Igg Subclasses Rid Combi Kit (Modification)DAS · Traditional | Research Diagnostics, Inc. | 09/07/1994SE |
| K943098 | Human Igg Subclasses Elisa Combi KitDAS · Traditional | Research Diagnostics, Inc. | 09/07/1994SE |
| K895600 | Human (Igg) Subclass (Eia) KitDAS · Traditional | The Binding Site, Ltd. | 11/08/1989SE |
| K790715 | Antiserum to Human FCDAS · Traditional | Kent Laboratories, Inc. | 08/16/1979SE |
| K761156 | Aminoglycoside ControlsDAS · Traditional | Supelco, Inc. | 12/09/1976SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K951966 | Human Prealbumin Radial Immunodiffusion KitJZJ · Traditional | 06/01/1995SE |
| K951968 | Human C1Q Radial Immunodiffusion KitDAK · Traditional | 05/30/1995SE |
| 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 Human Ig G FC Fragments cleared by the FDA?
Antiserum to Human Ig G FC Fragments (K790708) received a 510(k) decision of Substantially Equivalent on August 22, 1979, 132 days after the submission was received.
What is the product code of K790708?
The FDA product code is DAS – Igg (Fc Fragment Specific), Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5530.