Vidas CMV Igm Assay
FDA 510(k) K933549 · Biomerieux Vitek, Inc.
510(k) numberK933549
Submission
- Device name
- Vidas CMV Igm Assay
- Applicant
- Biomerieux Vitek, Inc.
Rockland, MA, US - Received
- July 22, 1993
- Decision date
- August 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKQ – Antibody Igm,If, Cytomegalovirus Virus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
Other 510(k)s with product code LKQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100433 | Immulite 2000 CMV Igm, Immulite CMV Igm Controls, and Immulite 200 CMV Igm Adjustor…LKQ · Traditional | Siemens Healthcare Diagnostics | 05/13/2010SE |
| K972884 | Accurun 146 CMV Igm Positive ControlLKQ · Traditional | Boston Biomedica, Inc. | 08/22/1997SE |
| K922580 | Bartels Cytomegalovirus Igm EiaLKQ · Traditional | Baxter Diagnostics, Inc. | 04/08/1993SE |
| K914789 | Elisa CMV IgmLKQ · Traditional | Sclavo, Inc. | 03/04/1992SE |
| K913080 | Opus(R) Anti Cmv-MLKQ · Traditional | Pb Diagnostics, Inc. | 10/28/1991SE |
| K900743 | Cmv-Igm Ifa Test SystemLKQ · Traditional | Zeus Scientific, Inc. | 04/26/1990SE |
| K893465 | CMV Igm Antibody Test (Indirect Fluorescent Test)LKQ · Traditional | Immuno Concepts, Inc. | 07/25/1989SE |
| K893466 | CMV Igm Antibody Test (Indirect Enzyme Test)LKQ · Traditional | Immuno Concepts, Inc. | 07/14/1989SE |
| K872881 | Abbott Cmv-M Eia KitLKQ · Traditional | Abbott Laboratories | 05/13/1988SE |
| K872942 | Igm CMV Clin-Elisa(Tm) Test System Number: 5530LKQ · Traditional | Clinical Sciences, Inc. | 01/11/1988SE |
More from Clinical Sciences, Inc.
| 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 CMV Igm Assay cleared by the FDA?
Vidas CMV Igm Assay (K933549) received a 510(k) decision of Substantially Equivalent on August 2, 1994, 376 days after the submission was received.
What is the product code of K933549?
The FDA product code is LKQ – Antibody Igm,If, Cytomegalovirus Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.