ABBOTT AXSYM HBSAG
FDA premarket approval P050049/S002 · decided 2007-12-19
Approval details
- PMA number
- P050049
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ABBOTT AXSYM HBSAG
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories, Inc.
- Date received
- 2007-12-13
- Decision date
- 2007-12-19
- Days to decision
- 6 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR LABELING MODIFICATIONS THAT CLARIFIES THE MEANING OF THE FINAL INTERPRETATION REPEAT REACTIVE, NONCONFORMING FOR HBSAG IN THE AXSYM HBSAG CONFIRMATORY PACKAGE INSERT. ALSO, CHANGES TO THE AXSYM HBSAG PACKAGE INSERT TO ALIGN WITH THE REMOVAL OF THE TERM "REPEAT REACTIVE" FROM THE INTERPRETATION OF RESULTS FOR THE AXSYM HBSAG CONFIRMATORY ASSAYS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 (K090358) | Abbott Laboratories, Inc. | 2009-08-06 |
| CREATININE (K061193) | Abbott Laboratories, Inc. | 2006-06-23 |
| PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS (K051213) | Abbott Laboratories, Inc. | 2005-05-27 |
| FOX PLUS PTA CATHETER (K040954) | Abbott Laboratories, Inc. | 2004-05-11 |
| AXSYM CYCLOSPORINE (K040761) | Abbott Laboratories, Inc. | 2004-04-30 |
| GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT (K023062) | Abbott Laboratories, Inc. | 2002-09-30 |