125I-IGE Radioimmunoassay Kit
FDA 510(k) K801019 · Bio-Ria
510(k) numberK801019
Submission
- Device name
- 125I-IGE Radioimmunoassay Kit
- Applicant
- Bio-Ria
Mchenry, IL, US - Received
- April 30, 1980
- Decision date
- May 20, 1980
- 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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|---|---|---|---|
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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 |
| 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 |
|---|---|---|
| K812901 | 125I Ferritin Radioimmunoassay KitDBF · Traditional | 12/30/1981SE |
Questions and answers
When was 125I-IGE Radioimmunoassay Kit cleared by the FDA?
125I-IGE Radioimmunoassay Kit (K801019) received a 510(k) decision of Substantially Equivalent on May 20, 1980, 20 days after the submission was received.
What is the product code of K801019?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.