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FDA 510(k), K133751, DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
FDA 510(k), K133751, DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
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510(K) Number: K133751
Device Name: DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
Manufacturer: DIAMOND DIAGNOSTICS, INC
Device Classification Name: calibrator, secondary
Regulation Number: 862.1150
Classification Product Code: JIT
Date Received: 12/09/2013
Decision Date: 08/08/2014
Regulation Medical Specialty: Clinical Chemistry
Device Name: DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
Manufacturer: DIAMOND DIAGNOSTICS, INC
Device Classification Name: calibrator, secondary
Regulation Number: 862.1150
Classification Product Code: JIT
Date Received: 12/09/2013
Decision Date: 08/08/2014
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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