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510(k) K863332

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

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)

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