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FDA 510(k), K964152, UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
FDA 510(k), K964152, UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
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510(K) Number: K964152
Device Name: UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
Manufacturer: PHARMACIA, INC.
Device Classification Name: ige, antigen, antiserum, control
Regulation Number: 866.5510
Classification Product Code: DGC
Date Received: 10/16/1996
Decision Date: 04/23/1997
Regulation Medical Specialty: Immunology
Device Name: UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
Manufacturer: PHARMACIA, INC.
Device Classification Name: ige, antigen, antiserum, control
Regulation Number: 866.5510
Classification Product Code: DGC
Date Received: 10/16/1996
Decision Date: 04/23/1997
Regulation Medical Specialty: Immunology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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