ARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL
FDA premarket approval P050042/S005 · decided 2009-06-23
Approval details
- PMA number
- P050042
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Abbott Laboratories, Inc.
- Date received
- 2009-01-28
- Decision date
- 2009-06-23
- Days to decision
- 146 days
- Decision code
- APPR
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL TO EXTEND THE APPLICATION OF THE ARCHITECT ANTI-HCV ASSAY, CURRENTLY APPROVED FOR USE ON THE ABBOTT ARCHITECT I2000/ I 2000SR, ONTO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I 1000SR.
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 |
|---|---|---|
| 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 |