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510(k) K841852

AUTOLYZER 800 by Geometric Data, Div. Smithkline Corp. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1984
Date Received
May 3, 1984
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 Geometric Data, Div. Smithkline Corp.

  • K811534 — HEMASPINNER (August 18, 1981)
  • K791041 — HEMATRAK ABNORMAL RECOGNITION (September 4, 1979)
  • K791108 — CONTEXT FILTER (July 17, 1979)
  • K790816 — HEMATRAK MODEL 480 (July 17, 1979)
  • K790042 — STAIN, HEMASTAIN RETIC (February 15, 1979)
  • K780577 — PLATELETS/CU MM (May 19, 1978)
  • K772139 — RE-CELL SLIDE RECAP (January 5, 1978)
  • K761207 — HEMATRAK RBC MORPHOLOGY (October 18, 1977)
  • K770680 — HEMATRAK (July 1, 1977)
  • K770550 — ATYPIA PROFILE MONITOR (June 17, 1977)

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