CELLFREE(R) INTERLEUKIN-2 RECEPTOR* BEAD ASSAT KIT
FDA premarket approval P880040/S003 · decided 1996-08-07
Approval details
- PMA number
- P880040
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CELLFREE(R) INTERLEUKIN-2 RECEPTOR* BEAD ASSAT KIT
- Generic name
- ASSAY, INTERLEUKIN
- Applicant
- Pierce Biotechnology, Inc.
- Date received
- 1995-03-24
- Decision date
- 1996-08-07
- Days to decision
- 502 days
- Decision code
- APPR
- Product code
- MAN
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Rockford, IL
- Statement
- APPROVAL FOR A CHANGE IN ADDRESS OF THE MANUFACTURING SITE AND UPDATES AND REVISIONS IN STANDARD OPERATING PROCEDURES AND MANUFACTURING INFORMATION
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