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510(k) K791644

ROYCO MODEL 371 SUPER DILUTOR by Royco Instruments — Product Code GKH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1979
Date Received
August 23, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Automated Blood Cell Diluting
Device Class
Class I
Regulation Number
864.5240
Review Panel
HE
Submission Type

Other clearances by Royco Instruments

  • K800104 — ROYCO MODEL 951 CELL MIXER (February 6, 1980)
  • K791867 — ROYCO MODEL 921 CELL COUNTER (November 5, 1979)
  • K790442 — ISOTONIC DILUENT (April 4, 1979)

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  • K882767 — SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM (July 18, 1988)
  • K852373 — AD150, AUTOMATED HEMATOLOGY DILUTOR (July 5, 1985)
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