K872881 is an FDA 510(k) clearance for the ABBOTT CMV-M EIA KIT. This device is classified as a Antibody Igm,if, Cytomegalovirus Virus (Class II - Special Controls, product code LKQ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 13, 1988, 296 days after receiving the submission on July 22, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K872881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1987 |
| Decision Date | May 13, 1988 |
| Days to Decision | 296 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LKQ — Antibody Igm,if, Cytomegalovirus Virus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3175 |