ARCHITECT CORE-M
FDA premarket approval P060035/S009 · decided 2011-06-24
Approval details
- PMA number
- P060035
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARCHITECT CORE-M
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories
- Date received
- 2011-05-25
- Decision date
- 2011-06-24
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE SUBJECT ARCHITECT ASSAYS.
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