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510(k) K870603

SYSTEM 9000 AUTOMATED CELL COUNTER by Baker Instructions Corp. — Product Code GKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1987
Date Received
February 11, 1987
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 Baker Instructions Corp.

  • K882612 — SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER (September 7, 1988)
  • K873596 — BAKER TDM THEOPHYLLINE ASSAY (October 20, 1987)
  • K854173 — UCD URINE SPECIMEN COLLECTOR (November 4, 1985)
  • K850386 — SYSTEM 8000 CELL COUNTER (May 2, 1985)
  • K833116 — SPIRIT CHEMISTRY SYSTEM (November 7, 1983)
  • K832716 — ENCORE CHEMISTRY ANALYZER (October 4, 1983)
  • K830641 — ENCORE CHEMISTRY ANALYZER (April 5, 1983)
  • K821956 — HAEM-C PLUS BLOOD REFERENCE CONTROLS (July 30, 1982)
  • K811694 — CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT (July 1, 1981)

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