FDA 510(k), K010670, PICCOLO CHLORIDE TEST SYSTEM

FDA 510(k), K010670, PICCOLO CHLORIDE TEST SYSTEM

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510(K) Number: K010670
Device Name: PICCOLO CHLORIDE TEST SYSTEM
Manufacturer: AMY LEVIN
Device Classification Name: Mercuric Thiocyanate, Colorimetry, Chloride
Regulation Number: CHJ
Classification Product Code: KXA
Date Received: 03/06/2001
Decision Date: 04/26/2001
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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