Antiserum to Human Igm
FDA 510(k) K790705 · Kent Laboratories, Inc.
510(k) numberK790705
Submission
- Device name
- Antiserum to Human Igm
- Applicant
- Kent Laboratories, Inc.
Mchenry, IL, US - Received
- April 12, 1979
- Decision date
- April 12, 1979
- Decision
- Unknown (SESP)
- Type
- Traditional 510(k)
Device classification
- Product code
- DAO – Igm (Mu Chain Specific), Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
Other 510(k)s with product code DAO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040431 | Roche Diagnostics Tina-Quant Igm GEN.2DAO · Special | Roche Diagnostics Corp. | 03/10/2004SE |
| K982639 | Spife Urine IfeDAO · Traditional | Helena Laboratories | 11/04/1998SE |
| K955908 | Boehringer Mannheim Igm AssayDAO · Traditional | Boehringer Mannheim Corp. | 02/09/1996SE |
| K850586 | SPQ Test System for Immunoglobulin MDAO · Traditional | Applications Lab | 03/14/1985SE |
| K841992 | Modification to Acs Coronary GuidingDAO · Traditional | Advanced Cardiovascular Systems, Inc. | 06/11/1984SE |
| K812487 | Immunogl. Frct. of Rabbit Antiser.-IgmDAO · Traditional | Dako Corp. | 09/23/1981SE |
| K800450 | Gemeni Igm AssayDAO · Traditional | Electro-Nucleonics Laboratories, Inc. | 04/24/1980SE |
More from Electro-Nucleonics 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 Antiserum to Human Igm cleared by the FDA?
Antiserum to Human Igm (K790705) received a 510(k) decision of Unknown on April 12, 1979, 0 days after the submission was received.
What is the product code of K790705?
The FDA product code is DAO – Igm (Mu Chain Specific), Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.