Vidas Total Ige (Ige) Assay
FDA 510(k) K931224 · Biomerieux Vitek, Inc.
510(k) numberK931224
Submission
- Device name
- Vidas Total Ige (Ige) Assay
- Applicant
- Biomerieux Vitek, Inc.
Rockland, MA, US - Received
- March 10, 1993
- Decision date
- May 20, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DGP – Ige, Fitc, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DGP
More from Intl. Diagnostic Technology
| 510(k) | Device | Decision |
|---|---|---|
| K973819 | Vidas D-Dimer (DD) AssayDAP · Traditional | 03/10/1998SE |
| K972895 | Vidas Rotavirus (RTV) AssayLIQ · Traditional | 10/03/1997SE |
| K965092 | Vidas Rotavirus AssayLIQ · Traditional | 05/05/1997SE |
| K964887 | Vidas C. Difficile Toxin a II AssayLLH · Traditional | 04/08/1997SE |
| K955627 | Vidas Chlamydia Blocking AssayLJC · Traditional | 10/07/1996SE |
| K962609 | Gram Negative Identification Plus CardLRH · Traditional | 08/30/1996SE |
| K962549 | Vidas Creatine Kinase MB Assay 30-421JHX · Traditional | 08/30/1996SE |
| K952095 | Vitek Gram Positive Identification Card (Gpi)LQL · Traditional | 03/12/1996SE |
| K955647 | Vidas Estradiol II (E2II) AssayCHP · Traditional | 02/06/1996SE |
| K943812 | Vidas Lyme Screen IILSR · Traditional | 06/13/1995SE |
Questions and answers
When was Vidas Total Ige (Ige) Assay cleared by the FDA?
Vidas Total Ige (Ige) Assay (K931224) received a 510(k) decision of Substantially Equivalent on May 20, 1993, 71 days after the submission was received.
What is the product code of K931224?
The FDA product code is DGP – Ige, Fitc, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.