VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATORS
FDA premarket approval P030024/S008 · decided 2008-02-20
Approval details
- PMA number
- P030024
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATORS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics
- Date received
- 2008-01-23
- Decision date
- 2008-02-20
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- INTRODUCTION OF A NEW PIECE OF AUTOMATED EQUIPMENT THAT REPLACES A MANUAL ASSEMBLY OPERATION.
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