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510(k) K024002

PENTRA 80 by Abx Diagnostics — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2003
Date Received
December 4, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

Other clearances by Abx Diagnostics

  • K030799 — MICROS 60 (April 8, 2003)
  • K030144 — MODIFICATION TO PENTRA 60 AND PENTRA 60C+ (January 31, 2003)
  • K022200 — PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 (July 29, 2002)
  • K014203 — ABX MICROS 60 HEMATOLOGY ANALYZER (February 28, 2002)
  • K003677 — ABX PENTRA 60C+ HEMATOLOGY ANALYZER (December 26, 2000)
  • K002646 — ABX MICROS CRP (October 26, 2000)
  • K992511 — ABX PENTRA 60 HEMATOLOGY ANALYZER (October 15, 1999)
  • K991839 — ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER (August 11, 1999)
  • K990311 — VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER (March 31, 1999)

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