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: KXA
Date Received: 01/05/2001
Decision Date: 05/29/2001
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Toxicology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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