The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Architect Havab-m.
| Device ID | K063329 |
| 510k Number | K063329 |
| Device Name: | ABBOTT ARCHITECT HAVAB-M |
| Classification | Hepatitis A Test (antibody And Igm Antibody) |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park, IL 60064 -6095 |
| Contact | Joseph C Orlowski |
| Correspondent | Joseph C Orlowski ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park, IL 60064 -6095 |
| Product Code | LOL |
| CFR Regulation Number | 866.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-03 |
| Decision Date | 2007-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740011093 | K063329 | 000 |
| 00380740011086 | K063329 | 000 |
| 00380740011079 | K063329 | 000 |
| 00380740136611 | K063329 | 000 |
| 00380740131579 | K063329 | 000 |
| 00380740131562 | K063329 | 000 |
| 00380740136628 | K063329 | 000 |