ABBOTT HAVAB-M/HAVAB-M EIA/IMX HAVAB-M
FDA premarket approval P790019/S013 · decided 2002-09-05
Approval details
- PMA number
- P790019
- Supplement
- S013
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ABBOTT HAVAB-M/HAVAB-M EIA/IMX HAVAB-M
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Abbott Laboratories
- Date received
- 2001-10-03
- Decision date
- 2002-09-05
- Days to decision
- 337 days
- Decision code
- APPR
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park North, IL
- Statement
- APPROVAL TO ADD TESTING OF A SENSITIVITY PANEL FOR QUALIFICATION OF THE HEPATITIS A VIRUS EXTRACT USED IN THE HAVAB ASSAYS TO COAT THE SOLID PHASE OF THE BEAD AND TO TIGHTEN ASSAY ACCEPTANCE SPECIFICATIONS FOR HAV ANTIGEN QUALIFICATION.
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510(k) clearances by this applicant
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|---|---|---|
| Anti-HCV Next (K252424) | Abbott Laboratories | 2026-04-28 |
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| Alinity i Toxo IgM (K233932) | Abbott Laboratories | 2024-08-30 |
| TBI (K232669) | Abbott Laboratories | 2023-09-29 |
| HAVAb IgG II (K222850) | Abbott Laboratories | 2023-08-10 |
| Alinity h-series System (K220031) | Abbott Laboratories | 2023-08-04 |