Turbo-Rast Specific Ige Assay
FDA 510(k) K903000 · Ventrex Laboratories, Inc.
510(k) numberK903000
Submission
- Device name
- Turbo-Rast Specific Ige Assay
- Applicant
- Ventrex Laboratories, Inc.
Portland, ME, US - Received
- July 9, 1990
- Decision date
- July 31, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHR – Radioimmunoassay, Immunoglobulins (D, E)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code JHR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061970 | Elecsys Ige II ImmunoassayJHR · Special | Roche Diagnostics | 08/31/2006SE |
| K984326 | Elecys Ige AssayJHR · Traditional | Boehringer Mannheim Corp. | 02/08/1999SE |
| K960067 | Immilite Total IgeJHR · Traditional | Diagnostic Products Corp. | 02/14/1996SE |
| K931703 | Immulite Total IgeJHR · Traditional | Diagnostic Products Corp. | 08/16/1993SE |
| K901859 | Coat-A-Count Total Ige Irma, Catalog #IKIE1, IKIE2JHR · Traditional | Diagnostic Products Corp. | 05/03/1990SE |
| K882616 | Alternate Procedure, Pharmacia Ige EiaJHR · Traditional | Pharmacia, Inc. | 08/04/1988SE |
| K873077 | Pharmacia Ige EiaJHR · Traditional | Pharmacia, Inc. | 10/20/1987SE |
| K840103 | Radioimmunoassay for Total Ige HumanJHR · Traditional | Techniclone Intl. | 02/10/1984SE |
More from Techniclone Intl.
| 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 |
| K904330 | Turbo-Rast Specific Ige AssayDHB · Traditional | 12/07/1990SE |
| 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 (K903000) received a 510(k) decision of Substantially Equivalent on July 31, 1990, 22 days after the submission was received.
What is the product code of K903000?
The FDA product code is JHR – Radioimmunoassay, Immunoglobulins (D, E), a Class II (moderate risk) device regulated under 21 CFR 866.5510.