Mast Luminescent Allergy Sys
FDA 510(k) K841642 · Mast Immunosystems
510(k) numberK841642
Submission
- Device name
- Mast Luminescent Allergy Sys
- Applicant
- Mast Immunosystems
- Received
- April 20, 1984
- Decision date
- June 7, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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|---|---|---|---|
| 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 |
|---|---|---|
| K934524 | Mast Cla Allergy SystemDHB · Traditional | 03/07/1994SE |
| K926420 | Mast Cla Allergy SystemDHB · Traditional | 03/07/1994SE |
| K914850 | Chemiluminescent System Allergan Specific IgeDHB · Traditional | 12/09/1991SE |
| K910292 | Mast Cla Allergy SystemDHB · Traditional | 04/05/1991SE |
| K870966 | Total Ige MastickDHB · Traditional | 04/14/1987SE |
| K844629 | Mast Luminescent Allergy SystemDHB · Traditional | 04/12/1985SE |
| K843694 | Mast Allergy SystemDHB · Traditional | 04/12/1985SE |
| K834526 | Mast Inhalant ProfileDHB · Traditional | 04/04/1984SE |
| K833969 | Mast Total IgeDGC · Traditional | 01/04/1984SE |
| K833885 | Mast Inhalant ProfileDHB · Traditional | 01/04/1984SE |
Questions and answers
When was Mast Luminescent Allergy Sys cleared by the FDA?
Mast Luminescent Allergy Sys (K841642) received a 510(k) decision of Substantially Equivalent on June 7, 1984, 48 days after the submission was received.
What is the product code of K841642?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.