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510(k) K992140

PICCOLO METLYTE 7 REAGENT DISC by Abaxis, Inc. — Product Code JLB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1999
Date Received
June 24, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Atp And Creatine Kinase (Enzymatic), Creatine
Device Class
Class I
Regulation Number
862.1210
Review Panel
CH
Submission Type

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  • K051108 — PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM (July 8, 2005)
  • K040115 — PICCOLO MAGNESIUM TEST SYSTEM (January 30, 2004)
  • K023642 — PICCOLO TOTAL CHOLESTEROL TEST SYSTEM (January 24, 2003)

Other clearances for product code JLB

  • K971817 — OLYMPUS CK-MB REAGENT (June 11, 1997)
  • K782156 — UNITEST CREATINE KINASE (March 2, 1979)