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510(k) K942525

MEDICOUNT DEKA HEMATOLOGY ANALYZER by Cea America Corp. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1996
Date Received
May 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

Other clearances by Cea America Corp.

  • K834613 — WILCOR-XR RP MEDICAL FILM (March 5, 1984)
  • K834614 — WILCOR-XR RP-L MEDICAL FILM (March 5, 1984)
  • K834612 — WILCOR-XR RP-OG MEDICAL FILM (February 27, 1984)
  • K834611 — SINGUL-XR RP NON SCREEN MED. FILM (February 21, 1984)

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