Antisera to Human Fragment
FDA 510(k) K790711 · Kent Laboratories, Inc.
510(k) numberK790711
Submission
- Device name
- Antisera to Human Fragment
- Applicant
- Kent Laboratories, Inc.
Mchenry, IL, US - Received
- April 12, 1979
- Decision date
- September 4, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DFK – Igg (Fab Fragment Specific), Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5520
- Specialty
- Immunology
Other 510(k)s with product code DFK
More from Kent Laboratories, Inc.
| 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 Antisera to Human Fragment cleared by the FDA?
Antisera to Human Fragment (K790711) received a 510(k) decision of Substantially Equivalent on September 4, 1979, 145 days after the submission was received.
What is the product code of K790711?
The FDA product code is DFK – Igg (Fab Fragment Specific), Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5520.