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510(k) K863332

ATAC 4300 HEMATOLOGY CELL COUNTER by Turpen Laboratory Systems, Inc. — Product Code GKL

K863332 is an FDA 510(k) premarket notification submitted by Turpen Laboratory Systems, Inc. for the device "ATAC 4300 HEMATOLOGY CELL COUNTER". The FDA issued a decision of Substantially Equivalent on September 29, 1986. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Turpen Laboratory Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1986
Date Received
August 27, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Cell, Automated (Particle Counter)
Device Class
Class II
Regulation Number
864.5200
Review Panel
HE
Submission Type

Other clearances by Turpen Laboratory Systems, Inc.

  • K870836 — ATAC 1500 CHEMISTRY ANALYZER (April 1, 1987)
  • K851321 — ATAC 2000 CHEMISTRY ANALYZER (April 25, 1985)
  • K843059 — ATAC 2000 (October 11, 1984)
  • K832115 — ATAC 3000 (January 10, 1984)
  • K832116 — ATAC 4700 HEMATOLOGY CELL COUNTER (October 20, 1983)

Other clearances for product code GKL

  • K152776 — Glocyte Automated Cell Counter System (May 27, 2016)
  • K091539 — IQ 200 URINE ANALIZER BODY FLUIDS MODULE (August 31, 2010)
  • K071652 — HEMOCUE WBC SYSTEM (October 25, 2007)
  • K051693 — MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM (December 7, 2005)
  • K050235 — IQ 200 URINE ANALYZER BODY FLUIDS MODULE (March 23, 2005)
  • K032677 — SYSMEX POCH-100I (February 11, 2004)
  • K022331 — ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD (September 11, 2002)
  • K001683 — SYSMEX R-500 (August 21, 2000)
  • K991070 — COULTER Z2 ANALYZER (May 11, 1999)
  • K981950 — SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 (November 3, 1998)

FDA data resources