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 |