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510(k) K850386

SYSTEM 8000 CELL COUNTER by Baker Instructions Corp. — Product Code GKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1985
Date Received
February 1, 1985
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.

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  • K870603 — SYSTEM 9000 AUTOMATED CELL COUNTER (March 31, 1987)
  • K854173 — UCD URINE SPECIMEN COLLECTOR (November 4, 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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