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510(k) K014203

ABX MICROS 60 HEMATOLOGY ANALYZER by Abx Diagnostics — Product Code GKX

K014203 is an FDA 510(k) premarket notification submitted by Abx Diagnostics for the device "ABX MICROS 60 HEMATOLOGY ANALYZER". The FDA issued a decision of Substantially Equivalent on February 28, 2002. The device falls under product code GKX (Instrument, Automated Platelet Counting), a Class II device regulated under 21 CFR 864.5200. Abx Diagnostics has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2002
Date Received
December 21, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Automated Platelet Counting
Device Class
Class II
Regulation Number
864.5200
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)
  • K024002 — PENTRA 80 (January 3, 2003)
  • K022200 — PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 (July 29, 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)

Other clearances for product code GKX

  • K840948 — CLEAR POROUS PLASTIC-HYPOALLERGENIC (August 14, 1984)

FDA data resources