The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Architect Havab-g.
| Device ID | K113704 |
| 510k Number | K113704 |
| Device Name: | ARCHITECT HAVAB-G |
| Classification | Hepatitis A Test (antibody And Igm Antibody) |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT. 09VA, BLDG. AP5 NORTH Abbott Park, IL 60064 -6092 |
| Contact | Judith Wallach |
| Correspondent | Judith Wallach ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT. 09VA, BLDG. AP5 NORTH Abbott Park, IL 60064 -6092 |
| Product Code | LOL |
| Subsequent Product Code | JIS |
| Subsequent Product Code | MJX |
| Subsequent Product Code | MJY |
| CFR Regulation Number | 866.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-16 |
| Decision Date | 2012-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740011185 | K113704 | 000 |
| 00380740011178 | K113704 | 000 |
| 00380740011161 | K113704 | 000 |
| 00380740131371 | K113704 | 000 |