FDA 510(k), K992140, PICCOLO METLYTE 7 REAGENT DISC

FDA 510(k), K992140, PICCOLO METLYTE 7 REAGENT DISC

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510(K) Number: K992140
Device Name: PICCOLO METLYTE 7 REAGENT DISC
Manufacturer: ABAXIS, INC.
Device Classification Name: atp and creatine kinase (enzymatic), creatine
Regulation Number: 862.1210
Classification Product Code: JLB
Date Received: 06/24/1999
Decision Date: 08/26/1999
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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