K100903 is an FDA 510(k) clearance for the ANTI-HAV. This device is classified as a Hepatitis A Test (antibody And Igm Antibody) (Class II - Special Controls, product code LOL).
Submitted by Roche Professional Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on October 5, 2010, 187 days after receiving the submission on April 1, 2010.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3310.
| 510(k) Number | K100903 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2010 |
| Decision Date | October 05, 2010 |
| Days to Decision | 187 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LOL — Hepatitis A Test (antibody And Igm Antibody) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3310 |