K063329 is an FDA 510(k) clearance for the ABBOTT ARCHITECT HAVAB-M. 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 April 16, 2007, 164 days after receiving the submission on November 3, 2006.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3310.
| 510(k) Number | K063329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2006 |
| Decision Date | April 16, 2007 |
| Days to Decision | 164 days |
| Submission Type | Abbreviated |
| 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 |