Total Ige Fast Test
FDA 510(k) K834594 · Allergenetics
510(k) numberK834594
Submission
- Device name
- Total Ige Fast Test
- Applicant
- Allergenetics
Mchenry, IL, US - Received
- December 29, 1983
- Decision date
- February 10, 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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| K063425 | Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…DGC · Traditional | Dade Behring, Inc. | 02/15/2007SE |
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| K042241 | K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093CDGC · Traditional | Kamiya Biomedical Co. | 12/10/2004SE |
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More from Adiatec SA
| 510(k) | Device | Decision |
|---|---|---|
| K851512 | Allergenetics Ige Fast TestDHB · Traditional | 05/28/1985SE |
| K842970 | Allergentics Total Ige/TheophyllineJJY · Traditional | 08/29/1984SE |
| K842969 | Allergenetics Aller-Specific Ige SerumDGP · Traditional | 08/28/1984SE |
| K833418 | Chymofast TestDHB · Traditional | 03/12/1984SE |
| K833419 | Labeled 125I Anti-IgeDGC · Traditional | 02/03/1984SE |
| K834244 | Theofast Test Kit for Quantitative TheoKLS · Traditional | 01/24/1984SE |
| K822341 | Allergenetics Ige-Fast TestDGC · Traditional | 11/10/1982SE |
Questions and answers
When was Total Ige Fast Test cleared by the FDA?
Total Ige Fast Test (K834594) received a 510(k) decision of Substantially Equivalent on February 10, 1984, 43 days after the submission was received.
What is the product code of K834594?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.