Determ. Size 72 Radial-Human Igd
FDA 510(k) K831956 · Kent Laboratories, Inc.
510(k) numberK831956
Submission
- Device name
- Determ. Size 72 Radial-Human Igd
- Applicant
- Kent Laboratories, Inc.
Mchenry, IL, US - Received
- June 17, 1983
- Decision date
- July 18, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CZJ – Igd, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code CZJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092450 | Human Igd Kit for Use on SpaplusCZJ · Traditional | The Binding Site | 12/28/2009SE |
| K051299 | Igd Diagnostic Test KitsCZJ · Traditional | The Binding Site, Ltd. | 11/23/2005SE |
| K002561 | Sheep Anti-Human Igd Immunofixation Grade KitCZJ · Traditional | The Binding Site, Ltd. | 10/26/2000SE |
| K913671 | Human Igd Immunological NL Test KitCZJ · Traditional | The Binding Site, Ltd. | 12/02/1991SE |
| K883001 | QM300 Calibrator D PackCZJ · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 09/22/1988SE |
| K872834 | Titan Gel Ife Antiserum to IGD-9409 & IGE-9410CZJ · Traditional | Helena Laboratories | 08/12/1987SE |
| K772327 | Las-R Human Igd TestCZJ · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 02/28/1978SE |
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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 Determ. Size 72 Radial-Human Igd cleared by the FDA?
Determ. Size 72 Radial-Human Igd (K831956) received a 510(k) decision of Substantially Equivalent on July 18, 1983, 31 days after the submission was received.
What is the product code of K831956?
The FDA product code is CZJ – Igd, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.