Timothy Allergen Disc
FDA 510(k) K862174 · Immuno Nuclear Corp.
510(k) numberK862174
Submission
- Device name
- Timothy Allergen Disc
- Applicant
- Immuno Nuclear Corp.
Stillwater, MN, US - Received
- June 9, 1986
- Decision date
- August 6, 1986
- 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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| 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 |
|---|---|---|
| K863743 | Biotech's Ige Immuno Response Test Isotope UnitDHB · Traditional | 12/15/1986SE |
| K863973 | Elm Allergen DiscDHB · Traditional | 12/01/1986SE |
| K863844 | Immuno Biotech's Lamb's Quarters Allergen DiscDHB · Traditional | 10/29/1986SE |
| K863123 | Immuno Biotech Mugwart Allergen DiscDHB · Traditional | 10/01/1986SE |
| K863098 | Meadow Fescue Allergen DiscDHB · Traditional | 09/15/1986SE |
| K862266 | Maple Allergen DiscDHB · Traditional | 08/19/1986SE |
| K862939 | Orchard Grass Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862938 | June Grass Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862265 | Cottonwood Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862176 | Russian Thistle Allergen DiscDHB · Traditional | 08/15/1986SE |
Questions and answers
When was Timothy Allergen Disc cleared by the FDA?
Timothy Allergen Disc (K862174) received a 510(k) decision of Substantially Equivalent on August 6, 1986, 58 days after the submission was received.
What is the product code of K862174?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.