Total Ige Discs
FDA 510(k) K822206 · Kallestad Laboratories, Inc.
510(k) numberK822206
Submission
- Device name
- Total Ige Discs
- Applicant
- Kallestad Laboratories, Inc.
Mchenry, IL, US - Received
- July 26, 1982
- Decision date
- August 16, 1982
- 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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| 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 |
|---|---|---|
| K863681 | Pathfinder(Tm) Direct Antigen Detection SystemLJP · Traditional | 12/03/1986SE |
| K862917 | Pathfinder Rotavirus ChemiluminescentLIQ · Traditional | 10/22/1986SE |
| K863682 | Pathfinder(Tm) Specimen Collection KitJSM · Traditional | 10/10/1986SE |
| K862743 | Pathfinder(Tm) Respiratory Syncytial VirusGQG · Traditional | 09/29/1986SE |
| K862313 | Kallestad Sm/Rnp Test ReagentLKJ · Traditional | 08/06/1986SE |
| K862710 | Kallestad Ssa/Ssb Ena Test ReagentsLLL · Traditional | 07/29/1986SE |
| K855014 | Quantimetric Plus Calibrator/Control Set aJIX · Traditional | 03/14/1986SE |
| K855010 | Quantimetric Plus Igm Reagent KitDFT · Traditional | 02/28/1986SE |
| K855013 | Quantimetric Plus Support PackDEH · Traditional | 02/26/1986SE |
| K855012 | Quantimetric Plus C4 Reagent KitDBI · Traditional | 02/26/1986SE |
Questions and answers
When was Total Ige Discs cleared by the FDA?
Total Ige Discs (K822206) received a 510(k) decision of Substantially Equivalent on August 16, 1982, 21 days after the submission was received.
What is the product code of K822206?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.