K113704 is an FDA 510(k) clearance for the ARCHITECT HAVAB-G. This device is classified as a Hepatitis A Test (antibody And Igm Antibody) (Class II - Special Controls, product code LOL).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 28, 2012, 195 days after receiving the submission on December 16, 2011.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3310.
| 510(k) Number | K113704 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2011 |
| Decision Date | June 28, 2012 |
| Days to Decision | 195 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 |