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FDA 510(k), K003064, TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323
FDA 510(k), K003064, TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323
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510(K) Number: K003064
Device Name: TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323
Manufacturer: ROCHE DIAGNOSTICS CORP.
Device Classification Name: Transferrin, Antigen, Antiserum, Control
Regulation Number: 866.5880
Classification Product Code: DDG
Date Received: 10/02/2000
Decision Date: 05/01/2001
Regulation Medical Specialty: Immunology
Device Name: TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323
Manufacturer: ROCHE DIAGNOSTICS CORP.
Device Classification Name: Transferrin, Antigen, Antiserum, Control
Regulation Number: 866.5880
Classification Product Code: DDG
Date Received: 10/02/2000
Decision Date: 05/01/2001
Regulation Medical Specialty: Immunology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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