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FDA 510(k), K133002, i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
FDA 510(k), K133002, i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
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510(K) Number: K133002
Device Name: i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
Manufacturer: MELISSA ROBINSON
Device Classification Name: System, Test, Human Chorionic Gonadotropin
Regulation Number: DHA
Classification Product Code: 09/24/2013
Date Received: 04/16/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
Manufacturer: MELISSA ROBINSON
Device Classification Name: System, Test, Human Chorionic Gonadotropin
Regulation Number: DHA
Classification Product Code: 09/24/2013
Date Received: 04/16/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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