SPQ Test System for Immunoglobulin G
FDA 510(k) K850583 · Applications Lab
510(k) numberK850583
Submission
- Device name
- SPQ Test System for Immunoglobulin G
- Applicant
- Applications Lab
Scarborough, ME, US - Received
- February 13, 1985
- Decision date
- March 1, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DEW – Igg, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050113 | Tina-Quant Igg GEN.2DEW · Traditional | Roche Diagnostics Corp. | 02/08/2005SE |
| K040434 | Roche Diagnostics Tina-Quant Igg GEN.2DEW · Special | Roche Diagnostics Corp. | 03/10/2004SE |
| K010617 | Spife Ife Calibrator and Control KitDEW · Traditional | Helena Laboratories | 03/15/2001SE |
| K993928 | Wako-Igg Ii-Ha, Immunoglobulin Calibrator Set, Immunolobulin StandardDEW · Traditional | Wako Chemicals USA, Inc. | 01/18/2000SE |
| K993281 | K-Assay IggDEW · Traditional | Kamiya Biomedical Co. | 11/09/1999SE |
| K983221 | IggDEW · Traditional | Abbott Laboratories | 11/04/1998SE |
| K965108 | Synchron LX Systems Immunoglobulin G/A/M ReagentDEW · Traditional | Beckman Instruments, Inc. | 03/06/1997SE |
| K963974 | Image-Immunochemistry System Urine ImmunoglobulinDEW · Traditional | Beckman Instruments, Inc. | 03/06/1997SE |
| K963868 | Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm)DEW · Traditional | Beckman Instruments, Inc. | 02/10/1997SE |
| K962202 | Quantex IggDEW · Traditional | Instrumentation Laboratory CO | 09/26/1996SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K850587 | SPQ Test System for Alpha, - AntitrypsinDEM · Traditional | 03/14/1985SE |
| K850586 | SPQ Test System for Immunoglobulin MDAO · 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 |
| K850582 | SPQ Test System for Immunoglobulin aCZP · Traditional | 03/01/1985SE |
Questions and answers
When was SPQ Test System for Immunoglobulin G cleared by the FDA?
SPQ Test System for Immunoglobulin G (K850583) received a 510(k) decision of Substantially Equivalent on March 1, 1985, 16 days after the submission was received.
What is the product code of K850583?
The FDA product code is DEW – Igg, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.