FDA 510(k), K010045, INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST
FDA 510(k), K010045, INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST
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510(K) Number: K010045
Device Name: INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST
Manufacturer: NAISHU WANG
Device Classification Name: Enzyme Immunoassay, Phencyclidine
Regulation Number: LCM
Classification Product Code: 01/05/2001
Date Received: 05/29/2001
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Toxicology
Device Name: INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST
Manufacturer: NAISHU WANG
Device Classification Name: Enzyme Immunoassay, Phencyclidine
Regulation Number: LCM
Classification Product Code: 01/05/2001
Date Received: 05/29/2001
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Toxicology
- 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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