ANTI-HBC REAGENT PACK AND CALIBRATOR
FDA premarket approval P030026/S019 · decided 2010-07-16
Approval details
- PMA number
- P030026
- Supplement
- S019
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANTI-HBC REAGENT PACK AND CALIBRATOR
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2009-12-01
- Decision date
- 2010-07-16
- Days to decision
- 227 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHO-CLINICAL DIAGNOSTICS, INC. IN SOUTH WALES, UNITED KINGDOM.
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