SPQ Test System for Immunoglobulin M
FDA 510(k) K850586 · Applications Lab
510(k) numberK850586
Submission
- Device name
- SPQ Test System for Immunoglobulin M
- Applicant
- Applications Lab
Scarborough, ME, US - Received
- February 13, 1985
- Decision date
- March 14, 1985
- Decision
- Substantially Equivalent (SESE)
- 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 |
| 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 |
| K790705 | Antiserum to Human IgmDAO · Traditional | Kent Laboratories, Inc. | 04/12/1979SESP |
More from Kent Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850587 | SPQ Test System for Alpha, - AntitrypsinDEM · Traditional | 03/14/1985SE |
| K850603 | SPQ Test System for ALPHA(2) MacroglobulinDEB · Traditional | 03/05/1985SE |
| K850589 | SPQ Test System for TransferrinDDG · Traditional | 03/05/1985SE |
| K850588 | SPQ Test System for Complement C3CZW · Traditional | 03/05/1985SE |
| K850584 | SPQ Test System for HaptoglobinDAD · Traditional | 03/05/1985SE |
| K850590 | SPQ Test System for C-Reactive ProteinDCK · Traditional | 03/01/1985SE |
| K850585 | SPQ Test System for Complement C4DBI · Traditional | 03/01/1985SE |
| K850583 | SPQ Test System for Immunoglobulin GDEW · Traditional | 03/01/1985SE |
| K850582 | SPQ Test System for Immunoglobulin aCZP · Traditional | 03/01/1985SE |
Questions and answers
When was SPQ Test System for Immunoglobulin M cleared by the FDA?
SPQ Test System for Immunoglobulin M (K850586) received a 510(k) decision of Substantially Equivalent on March 14, 1985, 29 days after the submission was received.
What is the product code of K850586?
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.