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FDA 510(k), K923768, PULSE CRP TEST
FDA 510(k), K923768, PULSE CRP TEST
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510(K) Number: K923768
Device Name: PULSE CRP TEST
Manufacturer: ALLEN CHAN
Device Classification Name: C-Reactive Protein, Antigen, Antiserum, And Control
Regulation Number: DCK
Classification Product Code: KXA
Date Received: 07/28/1992
Decision Date: 12/01/1992
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Immunology
Device Name: PULSE CRP TEST
Manufacturer: ALLEN CHAN
Device Classification Name: C-Reactive Protein, Antigen, Antiserum, And Control
Regulation Number: DCK
Classification Product Code: KXA
Date Received: 07/28/1992
Decision Date: 12/01/1992
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Immunology
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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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