ELECSYS ANTI-HBC IGM IMMUNOASSAY
FDA premarket approval P110025/S013 · decided 2016-08-08
Approval details
- PMA number
- P110025
- Supplement
- S013
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ELECSYS ANTI-HBC IGM IMMUNOASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Roche Diagnostics Corp.
- Date received
- 2016-01-27
- Decision date
- 2016-08-08
- Days to decision
- 194 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Approval for changes to the final kit packaging configuration, modifications to an existing packaging line, and addition of two new packaging lines.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM (K130138) | Roche Diagnostics Corp. | 2013-03-15 |
| ELECSYS CA 19-9 CALCHECK 5 (K101365) | Roche Diagnostics Corp. | 2010-10-05 |
| COBAS 8000 MODULAR SERIES ANALYZER (K100853) | Roche Diagnostics Corp. | 2010-09-09 |
| ACCU-CHEK ULTRFLEX INFUSION SET (K101196) | Roche Diagnostics Corp. | 2010-08-27 |
| AMPHETAMINES II ASSAY (K093664) | Roche Diagnostics Corp. | 2010-07-28 |
| ELECSYS INSULIN CALCHECK 5 (K101075) | Roche Diagnostics Corp. | 2010-06-11 |
| ELECSYS TESTOSTERONE II IMMUNOASSAY (K093421) | Roche Diagnostics Corp. | 2010-04-23 |
| ELECSYS TROPONIN T CALCHECK 5 (K092848) | Roche Diagnostics Corp. | 2010-03-19 |