ARCHITECT HAVAB-G

Hepatitis A Test (antibody And Igm Antibody)

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Architect Havab-g.

Pre-market Notification Details

Device IDK113704
510k NumberK113704
Device Name:ARCHITECT HAVAB-G
ClassificationHepatitis A Test (antibody And Igm Antibody)
Applicant ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT. 09VA, BLDG. AP5 NORTH Abbott Park,  IL  60064 -6092
ContactJudith Wallach
CorrespondentJudith Wallach
ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT. 09VA, BLDG. AP5 NORTH Abbott Park,  IL  60064 -6092
Product CodeLOL  
Subsequent Product CodeJIS
Subsequent Product CodeMJX
Subsequent Product CodeMJY
CFR Regulation Number866.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-16
Decision Date2012-06-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740011185 K113704 000
00380740011178 K113704 000
00380740011161 K113704 000
00380740131371 K113704 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.