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510(k) K832115

ATAC 3000 by Turpen Laboratory Systems, Inc. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1984
Date Received
June 30, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

Other clearances by Turpen Laboratory Systems, Inc.

  • K870836 — ATAC 1500 CHEMISTRY ANALYZER (April 1, 1987)
  • K863332 — ATAC 4300 HEMATOLOGY CELL COUNTER (September 29, 1986)
  • K851321 — ATAC 2000 CHEMISTRY ANALYZER (April 25, 1985)
  • K843059 — ATAC 2000 (October 11, 1984)
  • K832116 — ATAC 4700 HEMATOLOGY CELL COUNTER (October 20, 1983)

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