Abbott Cmv-M Eia Kit
FDA 510(k) K872881 · Abbott Laboratories
510(k) numberK872881
Submission
- Device name
- Abbott Cmv-M Eia Kit
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- July 22, 1987
- Decision date
- May 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKQ – Antibody Igm,If, Cytomegalovirus Virus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
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| 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 |
| 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 |
| K872942 | Igm CMV Clin-Elisa(Tm) Test System Number: 5530LKQ · Traditional | Clinical Sciences, Inc. | 01/11/1988SE |
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Questions and answers
When was Abbott Cmv-M Eia Kit cleared by the FDA?
Abbott Cmv-M Eia Kit (K872881) received a 510(k) decision of Substantially Equivalent on May 13, 1988, 296 days after the submission was received.
What is the product code of K872881?
The FDA product code is LKQ – Antibody Igm,If, Cytomegalovirus Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.