K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093C
FDA 510(k) K042241 · Kamiya Biomedical Co.
510(k) numberK042241
Submission
- Device name
- K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093C
- Applicant
- Kamiya Biomedical Co.
Tukwila, WA, US - Received
- August 19, 2004
- Decision date
- December 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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Questions and answers
When was K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093C cleared by the FDA?
K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093C (K042241) received a 510(k) decision of Substantially Equivalent on December 10, 2004, 113 days after the submission was received.
What is the product code of K042241?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.