ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG
FDA premarket approval P990012 · decided 2001-06-01
Approval details
- PMA number
- P990012
- Trade name
- ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Roche Diagnostics Corp.
- Date received
- 1999-03-04
- Decision date
- 2001-06-01
- Days to decision
- 820 days
- Decision code
- APWD
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- APPROVAL FOR THE ELECSYS. HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG. THE DEVICES ARE INDICATED FOR: ELECSYS HBSAG IMMUNOASSAY IS AN IMMUNOASSAY FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA-K3, SODIUM CITRATE). ASSAY RESULTS IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B. IN ADDITION, THIS A
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 |