Bioclone's Elegance Ige Elisa Kit
FDA 510(k) K910419 · Bioclone Australia Pty , Ltd.
510(k) numberK910419
Submission
- Device name
- Bioclone's Elegance Ige Elisa Kit
- Applicant
- Bioclone Australia Pty , Ltd.
Washington, DC, US - Received
- January 30, 1991
- Decision date
- June 21, 1991
- 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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More from Adiatec SA
| 510(k) | Device | Decision |
|---|---|---|
| K935049 | Elegance Neonatal TSH ElisaJLW · Traditional | 10/03/1994SE |
| K922284 | Elegance FT4 ElisaCEC · Traditional | 07/10/1992SE |
| K910420 | Bioclone's Elegance HCG Elisa KitJHI · Traditional | 02/26/1991SE |
| K905099 | Elegance TSH ElisaJLW · Traditional | 12/18/1990SE |
| K905098 | Elegance GH ElisaCFL · Traditional | 12/06/1990SE |
| K904822 | Elegance Ferritin ElisaDBF · Traditional | 11/29/1990SE |
| K904387 | Bioclones Elegance LH Elisa KitCEP · Traditional | 11/06/1990SE |
| K904483 | Elegance Prolactin ElisaCFT · Traditional | 11/05/1990SE |
| K904405 | Bioclones Elegance FSH Elisa KitCGJ · Traditional | 10/26/1990SE |
Questions and answers
When was Bioclone's Elegance Ige Elisa Kit cleared by the FDA?
Bioclone's Elegance Ige Elisa Kit (K910419) received a 510(k) decision of Substantially Equivalent on June 21, 1991, 142 days after the submission was received.
What is the product code of K910419?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.