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FDA 510(k), K110605, ROM PLUS
FDA 510(k), K110605, ROM PLUS
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510(K) Number: K110605
Device Name: ROM PLUS
Manufacturer: CLINICAL INNOVATIONS, LLC
Device Classification Name: immunoassay for detection of amniotic fluid protein(s).
Regulation Number: 862.1550
Classification Product Code: NQM
Date Received: 03/02/2011
Decision Date: 11/23/2011
Regulation Medical Specialty: Clinical Chemistry
Device Name: ROM PLUS
Manufacturer: CLINICAL INNOVATIONS, LLC
Device Classification Name: immunoassay for detection of amniotic fluid protein(s).
Regulation Number: 862.1550
Classification Product Code: NQM
Date Received: 03/02/2011
Decision Date: 11/23/2011
Regulation Medical Specialty: Clinical Chemistry
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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