Turbo-Rast Specific Ige Assay
FDA 510(k) K904330 · Ventrex Laboratories, Inc.
510(k) numberK904330
Submission
- Device name
- Turbo-Rast Specific Ige Assay
- Applicant
- Ventrex Laboratories, Inc.
Portland, ME, US - Received
- September 20, 1990
- Decision date
- December 7, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DHB – System, Test, Radioallergosorbent (Rast) Immunological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5750
- Specialty
- Immunology
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More from Hycor Biomedical
| 510(k) | Device | Decision |
|---|---|---|
| K914554 | Specific Ige Eia-Turbo AssayDHB · Traditional | 03/13/1992SE |
| K913833 | Ventrex Allergen DiscDHB · Traditional | 02/21/1992SE |
| K913434 | Ventrex Coated Tube Intact PTHCEW · Traditional | 10/25/1991SE |
| K905612 | Ventrex Coated Tube Ige RadioimmunoassayDGC · Traditional | 02/21/1991SE |
| K905636 | Ventrex Coated Tube Ige Enzyme ImmunoassayDHB · Traditional | 02/07/1991SE |
| K905247 | SHBG Irma KitCDZ · Traditional | 01/17/1991SE |
| K903000 | Turbo-Rast Specific Ige AssayJHR · Traditional | 07/31/1990SE |
| K897083 | Ventresign Strep a TestGTZ · Traditional | 01/22/1990SE |
| K895649 | Coated Tube High Sensitivity TSH 200 Uiu/Ml Stan.JIT · Traditional | 01/18/1990SE |
| K895648 | Coated Tube High Sensitivity TSH 100 Uiu/Ml Stan.JIT · Traditional | 01/18/1990SE |
Questions and answers
When was Turbo-Rast Specific Ige Assay cleared by the FDA?
Turbo-Rast Specific Ige Assay (K904330) received a 510(k) decision of Substantially Equivalent on December 7, 1990, 78 days after the submission was received.
What is the product code of K904330?
The FDA product code is DHB – System, Test, Radioallergosorbent (Rast) Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5750.