Roche Diagnostics Tina-Quant Igg GEN.2
FDA 510(k) K040434 · Roche Diagnostics Corp.
510(k) numberK040434
Submission
- Device name
- Roche Diagnostics Tina-Quant Igg GEN.2
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- February 19, 2004
- Decision date
- March 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K955798 | Igg Immunoturbidimetric & CalibratorDEW · Traditional | Randox Laboratories, Ltd. | 04/05/1996SE |
More from Randox Laboratories, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | 06/12/2026SE |
| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was Roche Diagnostics Tina-Quant Igg GEN.2 cleared by the FDA?
Roche Diagnostics Tina-Quant Igg GEN.2 (K040434) received a 510(k) decision of Substantially Equivalent on March 10, 2004, 20 days after the submission was received.
What is the product code of K040434?
The FDA product code is DEW – Igg, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.