AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS
FDA premarket approval P060009 · decided 2006-08-25
Approval details
- PMA number
- P060009
- Trade name
- AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories, Inc.
- Date received
- 2006-03-10
- Decision date
- 2006-08-25
- Days to decision
- 168 days
- Decision code
- APWD
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ABBOTT AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS. THESE DEVICES ARE INDICATED FOR: THEAXSYM CORE-M 2.0 IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE IN VITRO QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B VIRUS CORE ANTIGEN (IGM ANTI-HBC) IN ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN POTASSIUM EDTA, SODIUM CITRATE, SODIUM HEPARIN, LITHIUM HEPARIN, OR PLASMA SEPARATOR TUBES). THE ASSAY IS USED
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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 |