Tan Dem* - Ige Kit
FDA 510(k) K802913 · Hybritech, Inc.
510(k) numberK802913
Submission
- Device name
- Tan Dem* - Ige Kit
- Applicant
- Hybritech, Inc.
Mchenry, IL, US - Received
- November 18, 1980
- Decision date
- May 29, 1981
- 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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| K921763 | Tandem Icon QSR CKMB Immunoenzymetric AssayJHY · Traditional | 06/09/1992SE |
| K912439 | Tandem-E TSH Calibration Verification Control SetJJX · Traditional | 08/28/1991SE |
| K911417 | Icon Strep B Immunoenzymetric AssayGTZ · Traditional | 07/24/1991SE |
Questions and answers
When was Tan Dem* - Ige Kit cleared by the FDA?
Tan Dem* - Ige Kit (K802913) received a 510(k) decision of Substantially Equivalent on May 29, 1981, 192 days after the submission was received.
What is the product code of K802913?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.