K222850 is an FDA 510(k) clearance for the HAVAb IgG II. 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 August 10, 2023, 323 days after receiving the submission on September 21, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3310.
| 510(k) Number | K222850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2022 |
| Decision Date | August 10, 2023 |
| Days to Decision | 323 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 |