Boehringer Mannheim Tina-Quant Ige Test
FDA 510(k) K983185 · Boehringer Mannheim Corp.
510(k) numberK983185
Submission
- Device name
- Boehringer Mannheim Tina-Quant Ige Test
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- September 11, 1998
- Decision date
- November 12, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DGC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231151 | Kenota 1 Total IgE; Kenota 1 (instrument)DGC · Dual Track | Kenota, Inc. | 05/31/2024SE |
| K214068 | Quantia IgEDGC · Special | Biokit, S.A. | 02/21/2023SE |
| K220178 | Total Immunoglobulin E (IgE)DGC · Traditional | Beckman Coulter, Inc. | 03/23/2022SE |
| K193493 | ADVIA Centaur Total IgE (tIgE)DGC · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/15/2020SE |
| K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE…DGC · Special | Phadia AB | 07/28/2016SE |
| K133404 | Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMHDGC · Special | Phadia AB | 02/24/2014SE |
| K063425 | Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…DGC · Traditional | Dade Behring, Inc. | 02/15/2007SE |
| K050493 | Quantia IgeDGC · Traditional | Biokit, S.A. | 08/16/2005SE |
| K042241 | K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093CDGC · Traditional | Kamiya Biomedical Co. | 12/10/2004SE |
| K034057 | LacrytestDGC · Traditional | Adiatec SA | 03/09/2004SE |
More from Adiatec SA
| 510(k) | Device | Decision |
|---|---|---|
| K984326 | Elecys Ige AssayJHR · Traditional | 02/08/1999SE |
| K983047 | Accu-Chek HQ SystemLFR · Traditional | 02/05/1999SE |
| K984419 | Elecsys Ige CalcheckJJY · Traditional | 02/02/1999SE |
| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | 10/27/1998SE |
| K982949 | Elecsys Psa, Model 2010LTJ · Traditional | 10/27/1998SE |
Questions and answers
When was Boehringer Mannheim Tina-Quant Ige Test cleared by the FDA?
Boehringer Mannheim Tina-Quant Ige Test (K983185) received a 510(k) decision of Substantially Equivalent on November 12, 1998, 62 days after the submission was received.
What is the product code of K983185?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.