Accurun 146 CMV Igm Positive Control
FDA 510(k) K972884 · Boston Biomedica, Inc.
510(k) numberK972884
Submission
- Device name
- Accurun 146 CMV Igm Positive Control
- Applicant
- Boston Biomedica, Inc.
West Bridgewater, MA, US - Received
- August 5, 1997
- Decision date
- August 22, 1997
- 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 |
| K933549 | Vidas CMV Igm AssayLKQ · Traditional | Biomerieux Vitek, Inc. | 08/02/1994SE |
| 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 |
|---|---|---|
| K032713 | Boston Biomedica, Inc. Borrelia Burgdorferi Igm and IggLSR · Traditional | 11/24/2003SE |
| K980351 | Bbi-Biotech Research Laboratories B. Burgdorferi Igm Western Blot KitLSR · Traditional | 03/05/1999SE |
| K974811 | Accurun(Tm) 150 HSV Igg Positive ControlJJX · Traditional | 02/10/1998SE |
| K974810 | Accurun(Tm) 132 Borrelia Burdorferi Igm Positive ControlLSR · Traditional | 02/05/1998SE |
| K974809 | Accurun(Tm) 130 Borrelia Burgdorferi Igg Positive ControlLSR · Traditional | 02/05/1998SE |
| K974261 | Accurun 135 Toxoplasma Igg Positive ControlLJK · Traditional | 12/11/1997SE |
| K972986 | Accurun 140 Rubella Igg Positive ControlMJX · Traditional | 10/08/1997SE |
| K972048 | Accurun 117 Hbeag Positive ControlJJY · Traditional | 08/12/1997SE |
| K971657 | Accurun 121 Hav Igm Positive ControlJJY · Traditional | 08/12/1997SE |
| K972307 | Accurun 119 Anti-Hepatitis B E Antigen (Anti-Hbe) Positive ControlJJY · Traditional | 08/07/1997SE |
Questions and answers
When was Accurun 146 CMV Igm Positive Control cleared by the FDA?
Accurun 146 CMV Igm Positive Control (K972884) received a 510(k) decision of Substantially Equivalent on August 22, 1997, 17 days after the submission was received.
What is the product code of K972884?
The FDA product code is LKQ – Antibody Igm,If, Cytomegalovirus Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.