Approval for changes to the final kit packaging configuration, modifications to an existing packaging line, and addition of two new packaging lines.
| Device | ELECSYS HBEAG IMMUNOASSAY |
| Classification Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ROCHE DIAGNOSTICS OPERATIONS INC |
| Date Received | 2016-01-27 |
| Decision Date | 2016-08-08 |
| PMA | P130015 |
| Supplement | S005 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS OPERATIONS INC 9115 Hague Rd indianapolis, IN 46250 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P130015 | | Original Filing |
| S016 |
2018-10-09 |
30-day Notice |
| S015 |
2018-04-17 |
Real-time Process |
| S014 |
2017-10-11 |
Real-time Process |
| S013 |
2017-09-15 |
Normal 180 Day Track |
| S012 |
2017-08-03 |
30-day Notice |
| S011 |
2017-07-18 |
30-day Notice |
| S010 |
2017-05-24 |
30-day Notice |
| S009 |
2016-12-20 |
Normal 180 Day Track No User Fee |
| S008 |
2016-10-26 |
30-day Notice |
| S007 |
2016-04-28 |
Normal 180 Day Track |
| S006 |
2016-02-16 |
30-day Notice |
| S005 |
2016-01-27 |
135 Review Track For 30-day Notice |
| S004 |
2015-10-07 |
30-day Notice |
| S003 |
2015-06-29 |
30-day Notice |
| S002 |
2014-10-16 |
Real-time Process |
| S001 |
2014-05-23 |
30-day Notice |
NIH GUDID Devices