K100433 is an FDA 510(k) clearance for the IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,. This device is classified as a Antibody Igm,if, Cytomegalovirus Virus (Class II - Special Controls, product code LKQ).
Submitted by Siemens Healthcare Diagnostics (West Sacramento, US). The FDA issued a Cleared decision on May 13, 2010, 86 days after receiving the submission on February 16, 2010.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K100433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2010 |
| Decision Date | May 13, 2010 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LKQ — Antibody Igm,if, Cytomegalovirus Virus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3175 |