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510(k) K790042

STAIN, HEMASTAIN RETIC by Geometric Data, Div. Smithkline Corp. — Product Code GJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1979
Date Received
January 5, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stain, Reticulocyte
Device Class
Class I
Regulation Number
864.1850
Review Panel
HE
Submission Type

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  • K772139 — RE-CELL SLIDE RECAP (January 5, 1978)
  • K761207 — HEMATRAK RBC MORPHOLOGY (October 18, 1977)
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  • K770550 — ATYPIA PROFILE MONITOR (June 17, 1977)