K093955 is an FDA 510(k) clearance for the ANTI-HAV IGM. This device is classified as a Hepatitis A Test (antibody And Igm Antibody) (Class II - Special Controls, product code LOL).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on June 22, 2010, 181 days after receiving the submission on December 23, 2009.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3310.
| 510(k) Number | K093955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2009 |
| Decision Date | June 22, 2010 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LOL — Hepatitis A Test (antibody And Igm Antibody) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3310 |